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NCT Number: NCT02355314

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Avicenne, Bobigny, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Doppler-based renal

Other

Doppler-based renal : day 0 and day 3

blood sample and urine sample

Biological

blood sample and urine sample : day 0 and day 3

Primary outcomes

  1. 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

  1. Doppler-based renal resistive index

    Time frame: Day 3

  2. Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2

    Time frame: Day 0

  3. Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2

    Time frame: Day 3

  4. usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: R2D2

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2015
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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