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Clinical Trials/NCT02355314
NCT02355314CompletedNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne10 sites in 1 country367 target enrollmentStarted: December 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
367
Locations
10
Primary Endpoint
Doppler-based renal resistive index

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • Severe Chronic Renal Failure (clearance < 30 ml.min-1)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (10)

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