Clinical trial NCT02355314: Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
Official title: Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: ICU patients
Doppler-based renal
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Doppler-based renal resistive index
timeFrame: Day 0
Secondary outcomes:
measure: Doppler-based renal resistive index
timeFrame: Day 3
measure: Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
timeFrame: Day 0
measure: Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2
timeFrame: Day 3
measure: usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)
timeFrame: Day 0
Other outcomes:
Locations:
city: Bobigny
country: France
facility: CHU Avicenne
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied
city: Paris
country: France
facility: CHU Saint-Louis
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
Study officials:
affiliation: URCIP
name: Carine LABRUYERE, Chef de projet
role: STUDY_CHAIR
References:
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.
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.
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.