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

NCT02800135 | Terminated

• 3 other identifiers: 1408024141521A-112014-005146-22
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 4

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.

Conditions

Critical Illness; Oliguria

Outcome Measures

Primary Outcomes (1)

• Number of patients with renal recovery

  day 3

Secondary Outcomes (5)

• 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

Study Arms (1)

Furosemide stress test

EXPERIMENTAL

Drug: Furosemide

Interventions

Furosemide DRUG

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.

Furosemide stress test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Chronic kidney disease stage 4 or more
• Evidence of obstructive renal failure

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (4)

CHU de CLERMONT-FERRAND

Clermont-Ferrand, 63000, France

Location

CHU de MONTPELLIER

Montpellier, 34000, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

CHRU de STRASBOURG

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Critical Illness; Oliguria

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Michael DARMON, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: June 15, 2016
• Study Start: April 11, 2016
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)