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

NCT ID: NCT02800135

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-11

Study Completion Date

2018-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness Oliguria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Furosemide stress test

Group Type EXPERIMENTAL

Furosemide

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael DARMON, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de CLERMONT-FERRAND

Clermont-Ferrand, , France

Site Status

CHU de MONTPELLIER

Montpellier, , France

Site Status

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

CHRU de STRASBOURG

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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141521A-11

Identifier Type: OTHER

Identifier Source: secondary_id

2014-005146-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1408024

Identifier Type: -

Identifier Source: org_study_id

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