Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients Recovery in the Short Term
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02800135|
Recruitment Status : Terminated (departure of the coordinating investigator from another institution)
First Posted : June 15, 2016
Last Update Posted : June 14, 2019
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients|
|Actual Study Start Date :||April 11, 2016|
|Actual Primary Completion Date :||March 21, 2018|
|Actual Study Completion Date :||March 21, 2018|
|Experimental: Furosemide stress test||
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.
- Number of patients with renal recovery [ Time Frame: day 3 ]
- natriuresis(mmol/L) [ Time Frame: day 0 to day 3 ]
- fractional excretion of sodium(%) [ Time Frame: day 0 to day 3 ]
- fractional excretion of urea (%), [ Time Frame: day 0 to day 3 ]
- U/P urea ratio(mg.dl-1/ mg.dl-1) [ Time Frame: day 0 to day 3 ]
- U/P creatinine ratio (mg.dl-1/ mg.dl-1) [ Time Frame: day 0 to day 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800135
|CHU de CLERMONT-FERRAND|
|Clermont-ferrand, France, 63000|
|CHU de MONTPELLIER|
|Montpellier, France, 34000|
|CHU de SAINT-ETIENNE|
|Saint-etienne, France, 42000|
|CHRU de STRASBOURG|
|Strasbourg, France, 67000|
|Principal Investigator:||Michael DARMON, MD PhD||CHU de SAINT-ETIENNE|