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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Terminated

CT.gov ID

NCT02800135

Collaborator

(none)

Enrollment

Locations

Arm

23.3

Actual Duration (Months)

23.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

N/A

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 :

Apr 11, 2016

Actual Primary Completion Date :

Mar 21, 2018

Actual Study Completion Date :

Mar 21, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of patients with renal recovery [day 3]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de CLERMONT-FERRAND	Clermont-ferrand	France	63000
2	CHU de MONTPELLIER	Montpellier	France	34000
3	CHU de SAINT-ETIENNE	Saint-etienne	France	42000
4	CHRU de STRASBOURG	Strasbourg	France	67000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Michael DARMON, MD PhD, CHU de SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT02800135

Other Study ID Numbers:

1408024
141521A-11
2014-005146-22

First Posted:

Jun 15, 2016

Last Update Posted:

Jun 14, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Oliguria

Critical Illness

Furosemide

Study Results

No Results Posted as of Jun 14, 2019