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OpenTrials
Completed

NCT Number: NCT03211962

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Analysis of the predictive value of the urinary concentration of TIMP2-IGFBP7

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: ACR-CHECK

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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