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

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

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness; Oliguria
• Intervention / Treatment: Drug: Furosemide

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Montpellier, France, 34000
    • CHU de Montpellier
  • Saint-etienne, France, 42000
    • CHU de SAINT-ETIENNE
  • Strasbourg, France, 67000
    • CHRU de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with renal recovery	day 3

Secondary Outcome Measures

Outcome Measure	Time Frame
natriuresis(mmol/L)	day 0 to day 3
fractional excretion of sodium(%)	day 0 to day 3
fractional excretion of urea (%),	day 0 to day 3
U/P urea ratio(mg.dl-1/ mg.dl-1)	day 0 to day 3
U/P creatinine ratio (mg.dl-1/ mg.dl-1)	day 0 to day 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2016
• Primary Completion (Actual): March 21, 2018
• Study Completion (Actual): March 21, 2018

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: June 10, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urological Manifestations; Disease Attributes; Urination Disorders; Critical Illness; Oliguria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: 1408024; 141521A-11 (Other Identifier: ANSM); 2014-005146-22 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No