Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients (R2D2)

September 19, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.

Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.

The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • CHU Avicenne
      • Clermont Ferrand, France, 63000
        • Chu Gabriel Montpied
      • Paris, France, 75010
        • Chu Saint-Louis
      • Saint Etienne, France, 42000
        • Chu de Saint Etienne
      • Strasbourg, France, 67000
        • CHRU de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sinus rhythm
  • Use of conventional mechanical ventilation

Exclusion Criteria:

  • Refusal: patient, family or trusted person to participate in the study
  • Renal artery stenosis known
  • Pregnant
  • Severe Chronic Renal Failure (clearance < 30 ml.min-1)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICU patients requiring mechanical ventilation
Other: Doppler-based renal
Doppler-based renal : day 0 and day 3
Biological: blood sample and urine sample
blood sample and urine sample : day 0 and day 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doppler-based renal resistive index
Time Frame: Day 0
Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Doppler-based renal resistive index
Time Frame: Day 3
Day 3
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Time Frame: Day 0
Day 0
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Time Frame: Day 3
Day 3
usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Chair: Carine LABRUYERE, Chef de projet, URCIP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208184
  • ANSM (Other Identifier: 2022-A02513-40)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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