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

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Other: Doppler-based renal; Biological: blood sample and urine sample

• Registration Number: NCT02355314
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICU patients requiring mechanical ventilation	Doppler-based renal	-
ICU patients requiring mechanical ventilation	blood sample and urine sample	-

Primary Outcome Measures

Name	Time	Method
Doppler-based renal resistive index	Day 0	Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (5)

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHU Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

CHU Avicenne; 🇫🇷 Bobigny, France

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France

CHU Saint-Louis; 🇫🇷 Paris, France