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

NCT02355314 | Completed

• 2 other identifiers: 1208184ANSM
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Kidney Injury

Keywords

ICU patients; Doppler-based renal

Outcome Measures

Primary Outcomes (1)

• Doppler-based renal resistive index

  Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation

  Day 0

Secondary Outcomes (4)

• Doppler-based renal resistive index

  Day 3

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

  Day 0

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

  Day 3

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

  Day 0

Study Arms (1)

ICU patients requiring mechanical ventilation

EXPERIMENTAL

Other: Doppler-based renal; Biological: blood sample and urine sample

Interventions

Doppler-based renal OTHER

Doppler-based renal : day 0 and day 3

ICU patients requiring mechanical ventilation

blood sample and urine sample BIOLOGICAL

blood sample and urine sample : day 0 and day 3

ICU patients requiring mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sinus rhythm
• Use of conventional mechanical ventilation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (5)

CHU Avicenne

Bobigny, 93000, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

CHU Saint-Louis

Paris, 75010, France

Location

Chu de Saint Etienne

Saint-Etienne, 42000, France

Location

CHRU de Strasbourg

Strasbourg, 67000, France

Location

Related Publications (3)

• 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.

  PMID: 35074631 DERIVED

• 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.

  PMID: 34678845 DERIVED

• 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.

  PMID: 30291377 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carine LABRUYERE, Chef de projet

  URCIP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 4, 2015
• Study Start: December 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

FR (5)