Back to results

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

Primary Purpose

Critical Illness, Oliguria

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Furosemide

About this trial

This is an interventional diagnostic trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU de CLERMONT-FERRAND
CHU de MONTPELLIER
CHU de SAINT-ETIENNE
CHRU de STRASBOURG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Furosemide stress test

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with renal recovery

Secondary Outcome Measures

natriuresis(mmol/L)

fractional excretion of sodium(%)

fractional excretion of urea (%),

U/P urea ratio(mg.dl-1/ mg.dl-1)

U/P creatinine ratio (mg.dl-1/ mg.dl-1)

Full Information

NCT ID

NCT02800135

First Posted

December 18, 2015

Last Updated

June 12, 2019

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT02800135

Brief Title

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

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

departure of the coordinating investigator from another institution

Study Start Date

April 11, 2016 (Actual)

Primary Completion Date

March 21, 2018 (Actual)

Study Completion Date

March 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, Oliguria

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Furosemide stress test

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Furosemide

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of patients with renal recovery

Time Frame

day 3

Secondary Outcome Measure Information:

Title

natriuresis(mmol/L)

Time Frame

day 0 to day 3

Title

fractional excretion of sodium(%)

Time Frame

day 0 to day 3

Title

fractional excretion of urea (%),

Time Frame

day 0 to day 3

Title

U/P urea ratio(mg.dl-1/ mg.dl-1)

Time Frame

day 0 to day 3

Title

U/P creatinine ratio (mg.dl-1/ mg.dl-1)

Time Frame

day 0 to day 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael DARMON, MD PhD

Organizational Affiliation

CHU de SAINT-ETIENNE

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de CLERMONT-FERRAND

City

Clermont-ferrand

ZIP/Postal Code

63000

Country

France

Facility Name

CHU de MONTPELLIER

City

Montpellier

ZIP/Postal Code

34000

Country

France

Facility Name

CHU de SAINT-ETIENNE

City

Saint-etienne

ZIP/Postal Code

42000

Country

France

Facility Name

CHRU de STRASBOURG

City

Strasbourg

ZIP/Postal Code

67000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs