Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?

Heart Failure Clinical Trial

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Official title:

Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211962
• Other study ID #: RNI2015-09
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Transient renal insufficiency is frequently observed in the course of cardiovascular arrest. Although elevation of creatinine is reversible in a large majority of cases, severe renal insufficiency is sometimes observed and is associated with a dark prognosis. Any intervention that may limit the worsening of renal function may have an impact on patient mortality. There is currently no validated pharmacological treatment to limit the progression of ARI or to accelerate its recovery. A major challenge then concerns the detection of the reversible character of renal damage.

Renal biomarkers have been little studied in the prediction of severe ARI and mortality after cardiac arrest. The combination of TIMP2 (tissue inhibitor of metalloproteinase) and insulin-like growth factor binding protein (IGFBP7) in urine showed good diagnostic performance in the early detection of the risk of developing acute renal failure within 12 hours. Measured in the urine, the excretion of these two markers specifically reflects renal tubular lesions. Moreover, their rate seems to be strongly correlated with the severity of the tubular lesions.

Thus, it can be reasonably assumed that their very early dosing in post-cardiac arrest could detect the presence and severity of renal tubular lesions. A threshold to be defined would discriminate patients at risk of developing an ARI within 48 hours post ACR and to distinguish between severe transient and severe persistent lesions beyond 72 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years

• Cardio-circulatory arrest within 6 hours

• Person affiliated to a social security scheme

Exclusion Criteria:

• Acute renal failure requiring urgent ERA in the opinion of the resuscitator Anuria

• Chronic renal insufficiency stage 4-5 with a glomerular filtration rate estimated at less than 30 ml / min.

• Rapidly progressive renal disease (glomerulonephritis, HUS, obstruction ...) Renal Insufficiency

• Probable glomerular involvement (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis)

• Pregnant or nursing women

• Patient under tutelage or curatorship or deprived of public right.

• Transplantation

• Subject involved in another search including an exclusion period still in progress at pre-inclusion

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Arrest
• Heart Failure
• Renal Failure
• Renal Insufficiency

Intervention

Other:
• Analysis of urinary levels of TIMP2 and IGFBP7 within 6 hours after cardiac circulatory arrest
Analysis of urinary levels of TIMP2 and IGFBP7 within 6 hours after cardiac circulatory arrest

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the predictive value of the urinary concentration of TIMP2-IGFBP7		Analysis of the predictive value of the urinary concentration of TIMP2-IGFBP7 in the development of acute renal insufficiency defined by the KDIGO 3 stage within 48 hours after inclusion