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
Sponsored by
About this trial
This is an interventional diagnostic trial for Critical Illness
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
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Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients Recovery in the Short Term
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