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

Not Applicable

Terminated

• Conditions: Oliguria; Critical Illness
• Interventions: Drug: Furosemide

• Registration Number: NCT02800135
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-18
• Study Start: 2016-04-11
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Primary Completion: 2018-03-21
• Study Completion: 2018-03-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Furosemide stress test	Furosemide	-

Primary Outcome Measures

Name	Time	Method
Number of patients with renal recovery	day 3

Secondary Outcome Measures

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

Trial Locations

Locations (4)

CHU de CLERMONT-FERRAND; 🇫🇷 Clermont-ferrand, France

CHU de MONTPELLIER; 🇫🇷 Montpellier, France

CHRU de STRASBOURG; 🇫🇷 Strasbourg, France

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France