Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients (R2D2)
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Doppler-based renal
blood sample and urine sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Kidney Injury focused on measuring ICU patients, Doppler-based renal
Eligibility 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)
Sites / Locations
- CHU Avicenne
- CHU Gabriel Montpied
- CHU Saint-Louis
- Chu de Saint Etienne
- CHRU de Strasbourg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICU patients requiring mechanical ventilation
Arm Description
Outcomes
Primary Outcome Measures
Doppler-based renal resistive index
Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation
Secondary Outcome Measures
Doppler-based renal resistive index
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)
Full Information
NCT ID
NCT02355314
First Posted
January 22, 2015
Last Updated
September 19, 2016
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02355314
Brief Title
Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
Acronym
R2D2
Official Title
Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
ICU patients, Doppler-based renal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
367 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICU patients requiring mechanical ventilation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Doppler-based renal
Intervention Description
Doppler-based renal : day 0 and day 3
Intervention Type
Biological
Intervention Name(s)
blood sample and urine sample
Intervention Description
blood sample and urine sample : day 0 and day 3
Primary Outcome Measure Information:
Title
Doppler-based renal resistive index
Description
Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Doppler-based renal resistive index
Time Frame
Day 3
Title
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Time Frame
Day 0
Title
Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
Time Frame
Day 3
Title
usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carine LABRUYERE, Chef de projet
Organizational Affiliation
URCIP
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
CHU Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
CHU Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Chu de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42000
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35074631
Citation
Schnell D, Bourmaud A, Reynaud M, Rouleau S, Merdji H, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Darmon M. Performance of renal Doppler to predict the occurrence of acute kidney injury in patients without acute kidney injury at admission. J Crit Care. 2022 Jun;69:153983. doi: 10.1016/j.jcrc.2021.12.017. Epub 2022 Jan 21.
Results Reference
derived
PubMed Identifier
34678845
Citation
Saade A, Bourmaud A, Schnell D, Darmon M; R2D2 Study Group. Performance of Doppler-Based Resistive Index and Semiquantitative Renal Perfusion in Predicting Persistent Acute Kidney Injury According to Operator Experience: Post Hoc Analysis of a Prospective Multicenter Study. Crit Care Med. 2022 Apr 1;50(4):e361-e369. doi: 10.1097/CCM.0000000000005372.
Results Reference
derived
PubMed Identifier
30291377
Citation
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.
Results Reference
derived
Learn more about this trial
Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
We'll reach out to this number within 24 hrs