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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

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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: Doppler-based renal Biological: blood sample and urine sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
Study Start Date : December 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: ICU patients requiring mechanical ventilation 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355314


Locations
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France
CHU Avicenne
Bobigny, France, 93000
CHU Gabriel Montpied
Clermont Ferrand, France, 63000
CHU Saint-Louis
Paris, France, 75010
Chu de Saint Etienne
Saint Etienne, France, 42000
CHRU de Strasbourg
Strasbourg, France, 67000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Study Chair: Carine LABRUYERE, Chef de projet URCIP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02355314     History of Changes
Other Study ID Numbers: 1208184
ANSM ( Other Identifier: 2013-A00044-41 )
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
ICU patients
Doppler-based renal

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases