<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/NCT02228551</url>
  </required_header>
  <id_info>
    <org_study_id>S55822-S55712</org_study_id>
    <nct_id>NCT02228551</nct_id>
  </id_info>
  <brief_title>Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study</brief_title>
  <acronym>ARCPPS</acronym>
  <official_title>Augmented Renal Clearance in the Adult Non-critically Ill Surgery Patient: a Prospective Point Prevalance Study and Identification of Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a&#xD;
      measured 8-hour urinary creatinine clearance &gt;= 120 ml/min/1.73m²) in an adult non-critically&#xD;
      ill abdominal and trauma surgery population. Secondary objectives are the identification of&#xD;
      risk factors associated with ARC in this specific study population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a&#xD;
      measured 8-hour urinary creatinine clearance &gt;= 120 ml/min/1.73m²) in an adult non-critically&#xD;
      ill abdominal and trauma surgery population.&#xD;
&#xD;
      Secondary objectives are the identification of risk factors associated with ARC in this&#xD;
      specific study population.&#xD;
&#xD;
      In every included patient, an 8-hour urine collection was carried out over an 8-hour time&#xD;
      period to determine the CrCl8h. Participants were asked to empty the bladder at the start of&#xD;
      the collection. From then, patients were asked to collect urine in a recipient during the&#xD;
      following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ,&#xD;
      the collection bag was emptied at the start of the collection. After 8 hours, total urinary&#xD;
      volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were&#xD;
      determined by laboratory analysis (enzymatic analysis by Roche Diagnostics). Midterm serum&#xD;
      creatinine samples were obtained at 4 hours after the start of the urinary collection. Based&#xD;
      on these values, CrCl8h was calculated according to the standard formulas and normalized to a&#xD;
      body surface area (BSA) of 1.73m².&#xD;
&#xD;
      The following demographic and clinical data were prospectively recorded or calculated: age,&#xD;
      sex, total body weight, lean body weight, length, BMI, BSA, presence of an urinary catheter,&#xD;
      pre- or postoperative status, 'preoperative American society of anesthesiology' (ASA) score,&#xD;
      relevant medical history with respect to the kidney function or SCr levels (i.e. arterial&#xD;
      hypertension, chronic kidney disease, diabetes mellitus, paralyzed patients or patients with&#xD;
      amputated limb(s)), length of stay (LOS) since admission in the hospital until the day of&#xD;
      collection (LOShosp), since admission on the ward until the day of collection (LOSward),&#xD;
      since surgery until the day of collection (LOSsurgery), LOS in the hospital at discharge&#xD;
      (LOSdisch), number of surgical interventions since admission until the day of collection, the&#xD;
      mean daily volume of administered fluids based on the 3 days before the day of collection&#xD;
      (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during&#xD;
      d-3, d-2 and d-1 as well as d0, number of patients with one or more postoperative&#xD;
      complication(s) (POC), number of POCs per patient and the highest severity grade of POCs per&#xD;
      patient, C-reactive protein concentration (CRP) and white blood cell count (WBC) on d-1 or&#xD;
      d0, baseline SCr (i.e. a SCr value from maximum 1 year old collected during a consultation),&#xD;
      preoperative SCr (i.e. first SCr during hospital stay but before any surgical procedure) and&#xD;
      SCr at discharge from the hospital. From the surgical procedure closest to the day of&#xD;
      collection, we collected duration of anesthesia and surgical procedure, the administration of&#xD;
      vasopressor agents, the volume and type of resuscitation fluids administered during surgery&#xD;
      (i.e. crystalloids, colloids or blood derivates) and volumes of urine and blood loss.&#xD;
      Additionally, in abdominal surgery patients, following demographic data were collected:&#xD;
      elective or emergency surgical procedure, presence of a nasogastric tube and an ileo- or&#xD;
      colostoma on the day of collection, reason for admission (i.e. colorectal, hepatobiliary or&#xD;
      other), whether there was an oncologic indication for surgery and laparoscopic or open&#xD;
      surgery. In trauma surgery patients following demographic data were collected additionally:&#xD;
      the injury severity score (ISS) on admission, diagnosis at admission (i.e. trauma with&#xD;
      fracture, trauma without fracture, infection, removal of osteosynthesis material or other)&#xD;
      and type of fracture (if trauma with fracture). The type and severity of postoperative&#xD;
      complications were classified using the Clavien-Dindo classification. All data were retrieved&#xD;
      from the patient's computerized medical files and were registered in a patient study file&#xD;
      (appendix 9.3) and in a Microsoft Office Access 2007 database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of augmented renal clearance</measure>
    <time_frame>8 hours</time_frame>
    <description>The prevalence of augmented renal clearance was calculated as the number of patients demonstrating a measured urinary creatinine clearnace ≥ 120 mL/min/1.73m² divided by the total number of included patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic and clinical factors independantly associated with augmented renal clearance</measure>
    <time_frame>6 months</time_frame>
    <description>Demographic data, pre- or postoperative status, ASA score, relevant medical history with respect to the kidney function or SCr levels, interval from admission until the collection day, interval since surgery, LOS at discharge, number of surgical interventions, the mean daily volume of administered fluids based on the 3 days before the day of collection (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during d-3 until d0, patients with one or more postoperative complication (POC), number of POCs per patient and the highest severity grade of POCs per patient, CRP and white blood cell count (WBC) on d-1 or d0, baseline SCr, preoperative SCr and SCr at discharge from the hospital. From the surgical procedure closest to the day of collection, we collected duration of anesthesia and surgical procedure, the administration of vasopressor agents, the volume and type of resuscitation fluids administered during surgery and volumes of urine and blood loss.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">279</enrollment>
  <condition>Prevalence of Augmented Renal Clearance</condition>
  <condition>Risk Factors for Augmented Renal Clearance</condition>
  <arm_group>
    <arm_group_label>ARC PPS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Augmented renal clearance Point prevalence study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Augmented renal clearance Point prevalence study</intervention_name>
    <description>An 8-hour urine collection was carried out to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis. Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m².</description>
    <arm_group_label>ARC PPS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  On the recruitment days, all non-critically ill adult patients hospitalized at the&#xD;
             74-bed abdominal and 50-bed trauma surgery wards in the 1850-bed University Hospitals&#xD;
             Leuven were eligible for inclusion. On both wards, urinary collections are not&#xD;
             routinely performed as part of standard of care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were age younger than 18 years&#xD;
&#xD;
          -  Do not resuscitate (DNR) code ≥ 2&#xD;
&#xD;
          -  Discharge before 16 hour on the day of collection (d0)&#xD;
&#xD;
          -  Surgery on the day of collection Pregnancy, lactation&#xD;
&#xD;
          -  Renal replacement therapy&#xD;
&#xD;
          -  Non-Caucasian ethnicity&#xD;
&#xD;
          -  Isolation in order for source control due to infection with multi-drug resistant&#xD;
             organisms (MDRO)&#xD;
&#xD;
          -  Incontinence or the lack of cooperation&#xD;
&#xD;
          -  At the abdominal ward in particular&#xD;
&#xD;
          -  Women without an indwelling urinary catheter were also excluded due to the incapacity&#xD;
             of these patients to carry out the urinary collection in a safe and painless manner&#xD;
&#xD;
          -  During the urinary collection, patients with incomplete or doubtful urinary&#xD;
             collections were excluded&#xD;
&#xD;
          -  Patients could only be included once, except for those with incomplete urinary&#xD;
             collection at an earlier day of collection.&#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>Peter Declercq, PharmD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pharmacy Department, University Hospitals Leuven &amp; Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abdominal surgery ward and Trauma surgery ward, University Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Augmented renal clearance</keyword>
  <keyword>non-critically ill</keyword>
  <keyword>surgery</keyword>
  <keyword>prevalence</keyword>
  <keyword>risk factors</keyword>
  <!-- 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/NCT02228551
org study id: S55822-S55712
nct id: NCT02228551
lead sponsor: 
has dmc: No
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a
      measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically
      ill abdominal and trauma surgery population. Secondary objectives are the identification of
      risk factors associated with ARC in this specific study population.
This point prevalence study investigates the prevalence of augmented renal clearance (i.e. a
      measured 8-hour urinary creatinine clearance >= 120 ml/min/1.73m²) in an adult non-critically
      ill abdominal and trauma surgery population.

      Secondary objectives are the identification of risk factors associated with ARC in this
      specific study population.

      In every included patient, an 8-hour urine collection was carried out over an 8-hour time
      period to determine the CrCl8h. Participants were asked to empty the bladder at the start of
      the collection. From then, patients were asked to collect urine in a recipient during the
      following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ,
      the collection bag was emptied at the start of the collection. After 8 hours, total urinary
      volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were
      determined by laboratory analysis (enzymatic analysis by Roche Diagnostics). Midterm serum
      creatinine samples were obtained at 4 hours after the start of the urinary collection. Based
      on these values, CrCl8h was calculated according to the standard formulas and normalized to a
      body surface area (BSA) of 1.73m².

      The following demographic and clinical data were prospectively recorded or calculated: age,
      sex, total body weight, lean body weight, length, BMI, BSA, presence of an urinary catheter,
      pre- or postoperative status, 'preoperative American society of anesthesiology' (ASA) score,
      relevant medical history with respect to the kidney function or SCr levels (i.e. arterial
      hypertension, chronic kidney disease, diabetes mellitus, paralyzed patients or patients with
      amputated limb(s)), length of stay (LOS) since admission in the hospital until the day of
      collection (LOShosp), since admission on the ward until the day of collection (LOSward),
      since surgery until the day of collection (LOSsurgery), LOS in the hospital at discharge
      (LOSdisch), number of surgical interventions since admission until the day of collection, the
      mean daily volume of administered fluids based on the 3 days before the day of collection
      (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during
      d-3, d-2 and d-1 as well as d0, number of patients with one or more postoperative
      complication(s) (POC), number of POCs per patient and the highest severity grade of POCs per
      patient, C-reactive protein concentration (CRP) and white blood cell count (WBC) on d-1 or
      d0, baseline SCr (i.e. a SCr value from maximum 1 year old collected during a consultation),
      preoperative SCr (i.e. first SCr during hospital stay but before any surgical procedure) and
      SCr at discharge from the hospital. From the surgical procedure closest to the day of
      collection, we collected duration of anesthesia and surgical procedure, the administration of
      vasopressor agents, the volume and type of resuscitation fluids administered during surgery
      (i.e. crystalloids, colloids or blood derivates) and volumes of urine and blood loss.
      Additionally, in abdominal surgery patients, following demographic data were collected:
      elective or emergency surgical procedure, presence of a nasogastric tube and an ileo- or
      colostoma on the day of collection, reason for admission (i.e. colorectal, hepatobiliary or
      other), whether there was an oncologic indication for surgery and laparoscopic or open
      surgery. In trauma surgery patients following demographic data were collected additionally:
      the injury severity score (ISS) on admission, diagnosis at admission (i.e. trauma with
      fracture, trauma without fracture, infection, removal of osteosynthesis material or other)
      and type of fracture (if trauma with fracture). The type and severity of postoperative
      complications were classified using the Clavien-Dindo classification. All data were retrieved
      from the patient's computerized medical files and were registered in a patient study file
      (appendix 9.3) and in a Microsoft Office Access 2007 database.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Prevalence of augmented renal clearance
time frame: 8 hours
description: The prevalence of augmented renal clearance was calculated as the number of patients demonstrating a measured urinary creatinine clearnace ≥ 120 mL/min/1.73m² divided by the total number of included patients.
measure: Demographic and clinical factors independantly associated with augmented renal clearance
time frame: 6 months
description: Demographic data, pre- or postoperative status, ASA score, relevant medical history with respect to the kidney function or SCr levels, interval from admission until the collection day, interval since surgery, LOS at discharge, number of surgical interventions, the mean daily volume of administered fluids based on the 3 days before the day of collection (d-3, d-2, d-1) as well as on the day of collection (d0), the relevant co-medication during d-3 until d0, patients with one or more postoperative complication (POC), number of POCs per patient and the highest severity grade of POCs per patient, CRP and white blood cell count (WBC) on d-1 or d0, baseline SCr, preoperative SCr and SCr at discharge from the hospital. From the surgical procedure closest to the day of collection, we collected duration of anesthesia and surgical procedure, the administration of vasopressor agents, the volume and type of resuscitation fluids administered during surgery and volumes of urine and blood loss.
arm group label: ARC PPS
arm group type: Other
description: Augmented renal clearance Point prevalence study
intervention type: Other
intervention name: Augmented renal clearance Point prevalence study
description: An 8-hour urine collection was carried out to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis. Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m².
arm group label: ARC PPS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Declercq, PharmD.
role: Principal Investigator
affiliation: Pharmacy Department, University Hospitals Leuven & Department of Pharmaceutical and Pharmacological Sciences, KULeuven, Belgium
facility: 
country: Belgium
responsible party type: Sponsor