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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02800135
• Other study ID #: 1408024
• Secondary ID: 141521A-112014-0
• Status: Terminated
• Phase: N/A
• Start date: April 11, 2016
• Est. completion date: March 21, 2018

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Oliguria

Intervention

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.

Locations

Country	Name	City	State
France	CHU de CLERMONT-FERRAND	Clermont-ferrand
France	CHU de MONTPELLIER	Montpellier
France	CHU de SAINT-ETIENNE	Saint-etienne
France	CHRU de STRASBOURG	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with renal recovery		day 3
Secondary	natriuresis(mmol/L)		day 0 to day 3
Secondary	fractional excretion of sodium(%)		day 0 to day 3
Secondary	fractional excretion of urea (%),		day 0 to day 3
Secondary	U/P urea ratio(mg.dl-1/ mg.dl-1)		day 0 to day 3
Secondary	U/P creatinine ratio (mg.dl-1/ mg.dl-1)		day 0 to day 3