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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT03211962
Collaborator
(none)
77
1
24.9
3.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Analysis of urinary levels of TIMP2 and IGFBP7 within 6 hours after cardiac circulatory arrest

Study Design

Study Type:
Observational
Actual Enrollment :
77 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens Picardie France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT03211962
Other Study ID Numbers:
  • RNI2015-09
First Posted:
Jul 11, 2017
Last Update Posted:
Jul 20, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2020