<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03799250</url>
  </required_header>
  <id_info>
    <org_study_id>824-18</org_study_id>
    <nct_id>NCT03799250</nct_id>
  </id_info>
  <brief_title>Fluid Management in the Post Anesthesia Care Unit</brief_title>
  <official_title>Common Clinical Indices-guided Bolus-based vs. Continuous Fluid Management A Prospective, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have&#xD;
      addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies&#xD;
      focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more&#xD;
      common subject of research was- the correct evaluation of the dynamic fluid status of&#xD;
      patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic&#xD;
      therapy (GDHT) trials and has become a widely used approach in intraoperative fluid&#xD;
      management.&#xD;
&#xD;
      While there are numerous studies on the intraoperative outcome of GDHT, research on the&#xD;
      immediate postoperative outcome of GDHT therapy use is scarce.&#xD;
&#xD;
      In this study the investigators aim to evaluate the efficacy of bolus-based fluid management&#xD;
      guided by common clinical parameters in postoperative period in post-anesthesia care unit.&#xD;
&#xD;
      In this randomized clinical trial all patients will be randomized to one of the following&#xD;
      groups:&#xD;
&#xD;
      The control group will receive standard care which includes fluid maintenance program as&#xD;
      dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.&#xD;
&#xD;
      The GDT group will not receive any maintenance fluid. Fluid boluses will be given according&#xD;
      to the flowchart attached.&#xD;
&#xD;
      Measurements of hemodynamic variables including heart rate and automatic non-invasive blood&#xD;
      pressure measurements as well pulse oximetry as routine procedures will be recorded and&#xD;
      stored by Metavision system (iMDsoft company) at regular intervals, all according to standard&#xD;
      clinical practice.&#xD;
&#xD;
      Blood gases measurement will be performed upon admission and at discharge. Urine output will&#xD;
      be measured and recorded every hour.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study&#xD;
      protocol will be explained, questions answered and informed consent form will be signed by&#xD;
      one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic&#xD;
      visit, the process will take place in the entrance to the surgery room. Following surgery,&#xD;
      patients will be assessed for eligibility and randomized to one of the study arms.&#xD;
&#xD;
      The control group will receive standard care which includes fluid maintenance program as&#xD;
      dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.&#xD;
&#xD;
      Study Arm:&#xD;
&#xD;
      The GDT group will not receive any maintenance fluid. Fluid boluses will be given according&#xD;
      to the flowchart attached.&#xD;
&#xD;
      Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be&#xD;
      recorded according to community medical record.&#xD;
&#xD;
      Blood products will be administered according to departmental guidelines and clinician&#xD;
      decision unrelated to participation in the study.&#xD;
&#xD;
      Patients will be extubated, either in the operating room or postoperatively, when they&#xD;
      fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and&#xD;
      stable hemodynamics), according to clinical indication unrelated to the participation in the&#xD;
      study.&#xD;
&#xD;
      Measurements of hemodynamic variables including heart rate and automatic non-invasive blood&#xD;
      pressure measurements as well pulse oximetry as routine procedures will be recorded and&#xD;
      stored by Metavision system (iMDsoft company) at regular intervals, all according to standard&#xD;
      clinical practice.&#xD;
&#xD;
      Blood gases measurement will be performed upon admission and at discharge. Urine output will&#xD;
      be measured and recorded every hour.&#xD;
&#xD;
      Other laboratory exams will be taken based on the physician discretion unrelated to the&#xD;
      participation in the study.&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
      For each participating patient the following data will be collected and recorded:&#xD;
&#xD;
        1. Demographic data&#xD;
&#xD;
        2. Medical history including regular medications&#xD;
&#xD;
        3. Hemodynamic data including heart rate, automatic non-invasive blood pressure&#xD;
           measurements, temperature as well pulse oximetry as routine procedures will be recorded&#xD;
           and stored by Metavision system&#xD;
&#xD;
        4. Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake,&#xD;
           anesthetic complications.&#xD;
&#xD;
        5. Laboratory values&#xD;
&#xD;
        6. Length of stay in PACU&#xD;
&#xD;
        7. Length of stay in hospital&#xD;
&#xD;
        8. Post-operative pulmonary complications&#xD;
&#xD;
        9. Acute kidney injury&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention</measure>
    <time_frame>1 week post surgery</time_frame>
    <description>Postoperative complication rates according to the EPCO classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The total amount of fluid infused.</measure>
    <time_frame>1 week post operative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in PACU</measure>
    <time_frame>8 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>1 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pulmonary complications</measure>
    <time_frame>1 week after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>1 week after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Ringer's Lactate</condition>
  <arm_group>
    <arm_group_label>Goal Directed Hemodynamic Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The GDT (Goal Directed Therapy) group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.&#xD;
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record.&#xD;
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.&#xD;
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.&#xD;
Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU (Post Anesthesia Care Unit) stay.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ringer lactate</intervention_name>
    <description>Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU</description>
    <arm_group_label>Goal Directed Hemodynamic Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard care</intervention_name>
    <description>standard care</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient undergoing general surgery, vascular surgery or urological surgery and who are&#xD;
             expected to stay in the PACU for more than 8 hours.&#xD;
&#xD;
          -  Above 18 years old&#xD;
&#xD;
          -  Not requiring dialysis treatment&#xD;
&#xD;
          -  Not requiring advanced monitoring (arterial waveform analysis or cardiac output&#xD;
             monitoring)&#xD;
&#xD;
          -  Eligible for signing an informed consent prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Pregnancy&#xD;
&#xD;
          -  Inability to obtain an informed consent&#xD;
&#xD;
          -  Massive transfusion in OR (more than 5 blood products)&#xD;
&#xD;
          -  Colloids infusion needed&#xD;
&#xD;
          -  The requirement for greater than 0.1mcg/kg/min of noradrenaline at arrival to PACU&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadav O Sheffy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonid O Eidelman, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nadav Sheffy, MD</last_name>
    <phone>972522246447</phone>
    <email>nadavs1@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Binyamin Zeribi</last_name>
    <email>benjzr@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>nadav sheffy, md</last_name>
      <phone>972522246447</phone>
      <email>nadavs1@gmail.com</email>
    </contact>
    <investigator>
      <last_name>nadav sheffy, md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Cecconi M, Corredor C, Arulkumaran N, Abuella G, Ball J, Grounds RM, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy-what is the evidence in surgical patients? The effect on different risk groups. Crit Care. 2013 Mar 5;17(2):209. doi: 10.1186/cc11823.</citation>
    <PMID>23672779</PMID>
  </reference>
  <reference>
    <citation>Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.</citation>
    <PMID>16356219</PMID>
  </reference>
  <reference>
    <citation>Della Rocca G, Vetrugno L, Tripi G, Deana C, Barbariol F, Pompei L. Liberal or restricted fluid administration: are we ready for a proposal of a restricted intraoperative approach? BMC Anesthesiol. 2014 Aug 1;14:62. doi: 10.1186/1471-2253-14-62. eCollection 2014.</citation>
    <PMID>25104915</PMID>
  </reference>
  <reference>
    <citation>Malbouisson LMS, Silva JM Jr, Carmona MJC, Lopes MR, Assuncao MS, Valiatti JLDS, Simoes CM, Auler JOC Jr. A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery. BMC Anesthesiol. 2017 May 30;17(1):70. doi: 10.1186/s12871-017-0356-9.</citation>
    <PMID>28558654</PMID>
  </reference>
  <reference>
    <citation>Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.</citation>
    <PMID>12357146</PMID>
  </reference>
  <reference>
    <citation>Hand WR, Stoll WD, McEvoy MD, McSwain JR, Sealy CD, Skoner JM, Hornig JD, Tennant PA, Wolf B, Day TA. Intraoperative goal-directed hemodynamic management in free tissue transfer for head and neck cancer. Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1974-80. doi: 10.1002/hed.24362. Epub 2016 Feb 1.</citation>
    <PMID>26829494</PMID>
  </reference>
  <reference>
    <citation>Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.</citation>
    <PMID>29576114</PMID>
  </reference>
  <reference>
    <citation>Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.</citation>
    <PMID>29742967</PMID>
  </reference>
  <reference>
    <citation>Sanders GM. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection (Br J Surg) 2006; 93; 1069-1076. Br J Surg. 2006 Dec;93(12):1563. doi: 10.1002/bjs.5683. No abstract available.</citation>
    <PMID>17115398</PMID>
  </reference>
  <reference>
    <citation>Weinberg L, Ianno D, Churilov L, Chao I, Scurrah N, Rachbuch C, Banting J, Muralidharan V, Story D, Bellomo R, Christophi C, Nikfarjam M. Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial. PLoS One. 2017 Sep 7;12(9):e0183313. doi: 10.1371/journal.pone.0183313. eCollection 2017.</citation>
    <PMID>28880931</PMID>
  </reference>
  <reference>
    <citation>Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.</citation>
    <PMID>21873370</PMID>
  </reference>
  <reference>
    <citation>Van der Linden PJ, Dierick A, Wilmin S, Bellens B, De Hert SG. A randomized controlled trial comparing an intraoperative goal-directed strategy with routine clinical practice in patients undergoing peripheral arterial surgery. Eur J Anaesthesiol. 2010 Sep;27(9):788-93. doi: 10.1097/EJA.0b013e32833cb2dd.</citation>
    <PMID>20613538</PMID>
  </reference>
  <reference>
    <citation>Valentine RJ, Duke ML, Inman MH, Grayburn PA, Hagino RT, Kakish HB, Clagett GP. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. J Vasc Surg. 1998 Feb;27(2):203-11; discussion 211-2. doi: 10.1016/s0741-5214(98)70351-9.</citation>
    <PMID>9510275</PMID>
  </reference>
  <reference>
    <citation>Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.</citation>
    <PMID>25058504</PMID>
  </reference>
  <reference>
    <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation>
    <PMID>15273542</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>September 22, 2019</last_update_submitted>
  <last_update_submitted_qc>September 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799250
org study id: 824-18
nct id: NCT03799250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have
      addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies
      focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more
      common subject of research was- the correct evaluation of the dynamic fluid status of
      patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic
      therapy (GDHT) trials and has become a widely used approach in intraoperative fluid
      management.

      While there are numerous studies on the intraoperative outcome of GDHT, research on the
      immediate postoperative outcome of GDHT therapy use is scarce.

      In this study the investigators aim to evaluate the efficacy of bolus-based fluid management
      guided by common clinical parameters in postoperative period in post-anesthesia care unit.

      In this randomized clinical trial all patients will be randomized to one of the following
      groups:

      The control group will receive standard care which includes fluid maintenance program as
      dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.

      The GDT group will not receive any maintenance fluid. Fluid boluses will be given according
      to the flowchart attached.

      Measurements of hemodynamic variables including heart rate and automatic non-invasive blood
      pressure measurements as well pulse oximetry as routine procedures will be recorded and
      stored by Metavision system (iMDsoft company) at regular intervals, all according to standard
      clinical practice.

      Blood gases measurement will be performed upon admission and at discharge. Urine output will
      be measured and recorded every hour.
Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study
      protocol will be explained, questions answered and informed consent form will be signed by
      one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic
      visit, the process will take place in the entrance to the surgery room. Following surgery,
      patients will be assessed for eligibility and randomized to one of the study arms.

      The control group will receive standard care which includes fluid maintenance program as
      dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.

      Study Arm:

      The GDT group will not receive any maintenance fluid. Fluid boluses will be given according
      to the flowchart attached.

      Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be
      recorded according to community medical record.

      Blood products will be administered according to departmental guidelines and clinician
      decision unrelated to participation in the study.

      Patients will be extubated, either in the operating room or postoperatively, when they
      fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and
      stable hemodynamics), according to clinical indication unrelated to the participation in the
      study.

      Measurements of hemodynamic variables including heart rate and automatic non-invasive blood
      pressure measurements as well pulse oximetry as routine procedures will be recorded and
      stored by Metavision system (iMDsoft company) at regular intervals, all according to standard
      clinical practice.

      Blood gases measurement will be performed upon admission and at discharge. Urine output will
      be measured and recorded every hour.

      Other laboratory exams will be taken based on the physician discretion unrelated to the
      participation in the study.

      Data Collection:

      For each participating patient the following data will be collected and recorded:

        1. Demographic data

        2. Medical history including regular medications

        3. Hemodynamic data including heart rate, automatic non-invasive blood pressure
           measurements, temperature as well pulse oximetry as routine procedures will be recorded
           and stored by Metavision system

        4. Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake,
           anesthetic complications.

        5. Laboratory values

        6. Length of stay in PACU

        7. Length of stay in hospital

        8. Post-operative pulmonary complications

        9. Acute kidney injury
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention
time frame: 1 week post surgery
description: Postoperative complication rates according to the EPCO classification
measure: The total amount of fluid infused.
time frame: 1 week post operative
measure: Length of stay in PACU
time frame: 8 hours after surgery
measure: Length of stay in hospital
time frame: 1 month after surgery
measure: Post-operative pulmonary complications
time frame: 1 week after surgery
measure: Acute kidney injury
time frame: 1 week after surgery
arm group label: Goal Directed Hemodynamic Therapy
arm group type: Experimental
description: The GDT (Goal Directed Therapy) group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study.
arm group label: Control Group
arm group type: Active Comparator
description: The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU (Post Anesthesia Care Unit) stay.
intervention type: Drug
intervention name: Ringer lactate
description: Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU
arm group label: Goal Directed Hemodynamic Therapy
intervention type: Other
intervention name: standard care
description: standard care
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadav O Sheffy, MD
role: Principal Investigator
affiliation: Rabin Medical Center
last name: Leonid O Eidelman, MD
role: Study Chair
affiliation: Rabin Medical Center
last name: Nadav Sheffy, MD
phone: 972522246447
email: nadavs1@gmail.com
last name: Binyamin Zeribi
email: benjzr@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
citation: Cecconi M, Corredor C, Arulkumaran N, Abuella G, Ball J, Grounds RM, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy-what is the evidence in surgical patients? The effect on different risk groups. Crit Care. 2013 Mar 5;17(2):209. doi: 10.1186/cc11823.
PMID: 23672779
citation: Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
PMID: 16356219
citation: Della Rocca G, Vetrugno L, Tripi G, Deana C, Barbariol F, Pompei L. Liberal or restricted fluid administration: are we ready for a proposal of a restricted intraoperative approach? BMC Anesthesiol. 2014 Aug 1;14:62. doi: 10.1186/1471-2253-14-62. eCollection 2014.
PMID: 25104915
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responsible party type: Sponsor
sharing ipd: Undecided