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

Acute Kidney Injury Clinical Trial

— R2D2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355314
• Other study ID #: 1208184
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: September 19, 2016
• Start date: December 2013
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	CHU Avicenne	Bobigny
France	CHU Gabriel Montpied	Clermont Ferrand
France	CHU Saint-Louis	Paris
France	Chu de Saint Etienne	Saint Etienne
France	CHRU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Doppler-based renal resistive index	Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation	Day 0	No
Secondary	Doppler-based renal resistive index		Day 3	No
Secondary	Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2		Day 0	No
Secondary	Dosages NGAL plasmatique, NGAL urinaire, IGFBP-7, TIMP-2		Day 3	No
Secondary	usual urinary indices (Fractional excretion of urea, fractional excretion of sodium, ratio U / P urea ratio U / P creatinine)		Day 0	No