xml: <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/NCT06026475</url>
    </required_header>
    <id_info>
      <org_study_id>RGCIRC-GDFT</org_study_id>
      <nct_id>NCT06026475</nct_id>
    </id_info>
    <brief_title>Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Oncosurgeries</brief_title>
    <acronym>GDFT ERAS</acronym>
    <official_title>Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Onco-surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rajiv Gandhi Cancer Institute &amp; Research Center, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rajiv Gandhi Cancer Institute &amp; Research Center, India</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways&#xD;
        designed to achieve early recovery and reducing postoperative morbidity after surgical&#xD;
        procedures by maintaining preoperative organ function and reducing the profound stress&#xD;
        response following surgery .The key elements of ERAS protocols include preoperative&#xD;
        counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal&#xD;
        directed fluid therapy early mobilization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For the proposed study investigators plan to include total 60 patients with 30 each allotted&#xD;
        to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade&#xD;
        I/II/III, study will be conducted after obtaining written informed consent from all patients&#xD;
        and approval from the scientific committee and Institutional Review Board (IRB). All patients&#xD;
        will receive one-third starvation fluid as crystalloid during first hour of surgery . Night&#xD;
        prior to and on the day of surgery carbo load will be given to all patients according to the&#xD;
        protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP -&#xD;
        Radial),CVP(site IJV),core Temperature .&#xD;
  &#xD;
        Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure&#xD;
        Ventilation will be given to all patients.Patients will be allotted randomly to either Goal&#xD;
        Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous&#xD;
        Pressure - CVP guided fluid Therapy Group.&#xD;
  &#xD;
        During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss ,&#xD;
        Seum lactate levels will be noted.&#xD;
  &#xD;
        For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI)&#xD;
        ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value&#xD;
        &gt;11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV,&#xD;
        SV, SVI and SVRI shall be recorded.&#xD;
  &#xD;
        For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value&#xD;
        &lt; 8 colloid bolus of 200ml will be given and change in CVP value will be noted.&#xD;
  &#xD;
        Patients in both the groups will receive Noradrenaline infusion if MAP &lt;70 mmHg with optimal&#xD;
        fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit&#xD;
        &lt; 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds,&#xD;
        Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of&#xD;
        stay (hours in SICU) and any postoperative complications shall be noted.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 17, 2023</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>Patients in Conventional Group will be given intraoperative fluids guided by CVP Values .&#xD;
  Patients in GDFT Group will be given fluids guided by SVV values.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participant will be masked about allotment of interventional group either CVP or SVV .</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of ICU stay</measure>
      <time_frame>upto 5 days .</time_frame>
      <description>Time of shifting of patients in both group to the ward in hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative serum Lactate levels mmol/L</measure>
      <time_frame>upto 48 hours</time_frame>
      <description>Serum lactate levels will be measured in the SICU</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum Creatinine levels mg/dL.</measure>
      <time_frame>Upto 48 hours.</time_frame>
      <description>Serum Creatinine levels will be measured in the SICU .</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Fluid Loss</condition>
    <condition>Enhanced Recovery</condition>
    <arm_group>
      <arm_group_label>Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>When SVV values will increase above 11 colloid bolus 200ml will be administered. postbolus change in values of SVV , SV , SVI and CI shall be noted.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>When CVP values will decrease below 8 cmsH20 colloid bolus 200ml will be administered .Postbolus change in values shall be noted .</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Goal directed Fluid Therapy</intervention_name>
      <description>Patients will receive fluid during surgery with goal of maintaining SVV below 11</description>
      <arm_group_label>Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional Fluid Therapy</intervention_name>
      <description>Patients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20</description>
      <arm_group_label>Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Elective major open gastrointestinal Oncosurgeries .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal.&#xD;
  &#xD;
            -  Robotic surgery.&#xD;
  &#xD;
            -  Laparoscopic surgery.&#xD;
  &#xD;
            -  Arrythmias.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anita Kulkarni, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anita Kulkarni, MD</last_name>
      <phone>+91 9891064785</phone>
      <email>anitackulkarni@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shagun Bhatia, DNB</last_name>
      <phone>+91 9891769779</phone>
      <email>drshagun_2010@rediffmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Anita Kulkarni</name>
        <address>
          <city>New Delhi</city>
          <state>Please Select</state>
          <zip>110078</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anita Kulkarni, MD</last_name>
        <phone>+91 9891064785</phone>
        <email>anitackulkarni@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Shagun Bhatia, DNB</last_name>
        <phone>+91 9891769779</phone>
        <email>drshagun_2010@rediffmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <reference>
      <citation>Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.</citation>
      <PMID>29369117</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rajiv Gandhi Cancer Institute &amp; Research Center, India</investigator_affiliation>
      <investigator_full_name>Dr Anita Kulkarni</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Goal Directed Fluid Therapy</keyword>
    <keyword>Stroke volume variation</keyword>
    <keyword>Enhanced recovery after surgery</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026475
  org study id: RGCIRC-GDFT
  nct id: NCT06026475
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways
        designed to achieve early recovery and reducing postoperative morbidity after surgical
        procedures by maintaining preoperative organ function and reducing the profound stress
        response following surgery .The key elements of ERAS protocols include preoperative
        counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal
        directed fluid therapy early mobilization.
  For the proposed study investigators plan to include total 60 patients with 30 each allotted
        to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade
        I/II/III, study will be conducted after obtaining written informed consent from all patients
        and approval from the scientific committee and Institutional Review Board (IRB). All patients
        will receive one-third starvation fluid as crystalloid during first hour of surgery . Night
        prior to and on the day of surgery carbo load will be given to all patients according to the
        protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP -
        Radial),CVP(site IJV),core Temperature .
  
        Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure
        Ventilation will be given to all patients.Patients will be allotted randomly to either Goal
        Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous
        Pressure - CVP guided fluid Therapy Group.
  
        During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss ,
        Seum lactate levels will be noted.
  
        For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI)
        ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value
        >11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV,
        SV, SVI and SVRI shall be recorded.
  
        For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value
        < 8 colloid bolus of 200ml will be given and change in CVP value will be noted.
  
        Patients in both the groups will receive Noradrenaline infusion if MAP <70 mmHg with optimal
        fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit
        < 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds,
        Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of
        stay (hours in SICU) and any postoperative complications shall be noted.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients in Conventional Group will be given intraoperative fluids guided by CVP Values .
  Patients in GDFT Group will be given fluids guided by SVV values.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Participant will be masked about allotment of interventional group either CVP or SVV .
  measure: Duration of ICU stay
  time frame: upto 5 days .
  description: Time of shifting of patients in both group to the ward in hours.
  measure: Postoperative serum Lactate levels mmol/L
  time frame: upto 48 hours
  description: Serum lactate levels will be measured in the SICU
  measure: Serum Creatinine levels mg/dL.
  time frame: Upto 48 hours.
  description: Serum Creatinine levels will be measured in the SICU .
  arm group label: Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)
  arm group type: Active Comparator
  description: When SVV values will increase above 11 colloid bolus 200ml will be administered. postbolus change in values of SVV , SV , SVI and CI shall be noted.
  arm group label: Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .
  arm group type: Active Comparator
  description: When CVP values will decrease below 8 cmsH20 colloid bolus 200ml will be administered .Postbolus change in values shall be noted .
  intervention type: Procedure
  intervention name: Goal directed Fluid Therapy
  description: Patients will receive fluid during surgery with goal of maintaining SVV below 11
  arm group label: Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)
  intervention type: Procedure
  intervention name: Conventional Fluid Therapy
  description: Patients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20
  arm group label: Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Anita Kulkarni, MD
  role: Principal Investigator
  affiliation: Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India
  last name: Anita Kulkarni, MD
  phone: +91 9891064785
  email: anitackulkarni@gmail.com
  last name: Shagun Bhatia, DNB
  phone: +91 9891769779
  email: drshagun_2010@rediffmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: India
  citation: Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.
  PMID: 29369117
  responsible party type: Principal Investigator
  investigator affiliation: Rajiv Gandhi Cancer Institute & Research Center, India
  investigator full name: Dr Anita Kulkarni
  investigator title: Principal Investigator
  sharing ipd: No