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

NCT ID: NCT02355314

Last Updated: 2016-09-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

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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ICU patients requiring mechanical ventilation

Group Type EXPERIMENTAL

Doppler-based renal

Intervention Type OTHER

Doppler-based renal : day 0 and day 3

blood sample and urine sample

Intervention Type BIOLOGICAL

blood sample and urine sample : day 0 and day 3

Interventions

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Doppler-based renal

Doppler-based renal : day 0 and day 3

Intervention Type OTHER

blood sample and urine sample

blood sample and urine sample : day 0 and day 3

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
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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Carine LABRUYERE, Chef de projet

Role: STUDY_CHAIR

URCIP

Locations

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CHU Avicenne

Bobigny, , France

Site Status

CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

CHU Saint-Louis

Paris, , 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

References

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Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.

Reference Type DERIVED
PMID: 35074631 (View on PubMed)

Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.

Reference Type DERIVED
PMID: 34678845 (View on PubMed)

Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.

Reference Type DERIVED
PMID: 30291377 (View on PubMed)

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1208184

Identifier Type: -

Identifier Source: org_study_id

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