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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

Tracking Information
First Submitted Date July 6, 2017
First Posted Date July 11, 2017
Last Update Posted Date July 25, 2018
Actual Study Start Date February 1, 2017
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03211962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?
Official Title Can Urinary Concentrations of TIMP2 and IGFBP7 be Used to Predict Early Acute Renal Failure Following Cardiac Arrest?
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients admitted to resuscitation in the aftermath of cardiac arrest with renal failure
Condition
  • Renal Failure
  • Heart Failure
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 6, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2019
Estimated Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dimitri TITECA-BEAUPORT, Dr +33322456411 titeca-beauport.dimitri@chu-amiens.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03211962
Other Study ID Numbers RNI2015-09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date July 2018