Clinical trial NCT02800135: Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients Recovery in the Short Term
Official title: Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Critical Illness
Oliguria
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Number of patients with renal recovery
timeFrame: day 3
Secondary outcomes:
measure: natriuresis(mmol/L)
timeFrame: day 0 to day 3
measure: fractional excretion of sodium(%)
timeFrame: day 0 to day 3
measure: fractional excretion of urea (%),
timeFrame: day 0 to day 3
measure: U/P urea ratio(mg.dl-1/ mg.dl-1)
timeFrame: day 0 to day 3
measure: U/P creatinine ratio (mg.dl-1/ mg.dl-1)
timeFrame: day 0 to day 3
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU de CLERMONT-FERRAND
city: Montpellier
country: France
facility: CHU de MONTPELLIER
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
city: Strasbourg
country: France
facility: CHRU de STRASBOURG
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Michael DARMON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: