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

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ClinicalTrials.gov Identifier: NCT02355314
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE January 22, 2015
First Posted Date  ICMJE February 4, 2015
Last Update Posted Date September 20, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02355314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Doppler-based renal resistive index [ Time Frame: Day 3 ]
  • Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2 [ Time Frame: Day 0 ]
  • Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2 [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
Official Title  ICMJE Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: ICU patients requiring mechanical ventilation
Interventions:
  • Other: Doppler-based renal
  • Biological: blood sample and urine sample
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
367
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
400
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02355314
Other Study ID Numbers  ICMJE 1208184
ANSM ( Other Identifier: 2013-A00044-41 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Carine LABRUYERE, Chef de projet URCIP
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP