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

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ClinicalTrials.gov Identifier: NCT03211962
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

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Study Type : Observational
Estimated Enrollment : 200 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 : February 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest


Intervention Details:
  • 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


Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to resuscitation in the aftermath of cardiac arrest with renal failure
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211962


Contacts
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Contact: Dimitri TITECA-BEAUPORT, Dr +33322456411 titeca-beauport.dimitri@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Dimitri TITECA-BEAUPORT, Dr    +33322456411    titeca-beauport.dimitri@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03211962     History of Changes
Other Study ID Numbers: RNI2015-09
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tissue Inhibitor of Metalloproteinase-2
TIMP2 protein, human
Heart Failure
Heart Arrest
Renal Insufficiency
Acute Kidney Injury
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action