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Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients Recovery in the Short Term

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ClinicalTrials.gov Identifier: NCT02800135
Recruitment Status : Terminated (departure of the coordinating investigator from another institution)
First Posted : June 15, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Previous studies suggested usual urinary indices to perform poorly for separating transient from persistent AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis.

Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically ill patients. This stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage AKI. Additionally, FST performance was higher than those of usual renal biomarker. The limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria.

The primary objective of this study is to assess diagnostic performance of FST in differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic performance of FST in predicting need for renal replacement therapy, and to confirm FST results after adjustment for confounders.


Condition or disease Intervention/treatment Phase
Critical Illness Oliguria Drug: Furosemide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients
Actual Study Start Date : April 11, 2016
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Furosemide stress test Drug: Furosemide
1.0 mg/kg of intravenous furosemide. In order to minimize the risk of hypovolemia, urine output will be replaced ml for ml with either Ringers lactate or normal saline for six hours after the furosemide stress test.




Primary Outcome Measures :
  1. Number of patients with renal recovery [ Time Frame: day 3 ]

Secondary Outcome Measures :
  1. natriuresis(mmol/L) [ Time Frame: day 0 to day 3 ]
  2. fractional excretion of sodium(%) [ Time Frame: day 0 to day 3 ]
  3. fractional excretion of urea (%), [ Time Frame: day 0 to day 3 ]
  4. U/P urea ratio(mg.dl-1/ mg.dl-1) [ Time Frame: day 0 to day 3 ]
  5. U/P creatinine ratio (mg.dl-1/ mg.dl-1) [ Time Frame: day 0 to day 3 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age > 18 y.o)
  • AKI stage 1 or more according to KDIGO
  • Oliguria as defined by an oliguria lower than 0.5 mL/Kg
  • Affiliation to the National Medical Insurance

Exclusion Criteria:

  • Pregnancy
  • Chronic kidney disease stage 4 or more
  • Need for fluid bolus (>1000 mL crystalloids or equivalent) or need for vasopressors increases or introduction in the 2 hours preceding inclusion
  • Evidence of obstructive renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800135


Locations
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France
CHU de CLERMONT-FERRAND
Clermont-ferrand, France, 63000
CHU de MONTPELLIER
Montpellier, France, 34000
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
CHRU de STRASBOURG
Strasbourg, France, 67000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Michael DARMON, MD PhD CHU de SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02800135     History of Changes
Other Study ID Numbers: 1408024
141521A-11 ( Other Identifier: ANSM )
2014-005146-22 ( EudraCT Number )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Furosemide
Oliguria
Critical Illness
Disease Attributes
Pathologic Processes
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action