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Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery (PhosphoIRA)

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ClinicalTrials.gov Identifier: NCT02900313
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE September 14, 2016
Last Update Posted Date October 3, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2016)
Dosage of phosphorus [ Time Frame: 48 hour after cardiac surgery ]
Kinetic phosphorus during acute renal failure in postoperative cardiac surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02900313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery
Official Title  ICMJE Predictive Interest of Serum Phosphorus Level in the Early Diagnosis of Acute Renal Insufficiency in Post-operative Immediate at Patients Having Benefited From a Cardiac Surgery.
Brief Summary Cardiac surgery associated acute kidney injury is an independent factor of morbidity and mortality . Despite its delayed elevation, serum creatinine (Cr) remains the goal standard to diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of renal function in this context. Consequently, the purpose of this study is to evaluate the predictibility of Ph to detect both AKI induction and in a second time, renal recovery.
Detailed Description It is a one-year prospective diagnostic validation study included all patients > 18 years-odl admitted in our center after cardiac surgery. AKI is define according to KDIGO criteria and classified in the groups of severity according to the Cr elevation and the need of renal replacement therapy. Serum Cr and Ph are measured at baseline before surgery , at ICU admission, every 12 hours until ICU discharge and every 24 hours until hospital discharge. To evaluate the predictability of Of Ph to diagnose AKI, the postoperative Ph percentage of maximal elevation (%EPh) will be calculated. Then the diagnostic performance of %EPh wil be assessed by calculating the areas under the Receiver Operating Characteristic Curve (AUC) to determine an optimal threshold with sensibility, specificity, positive predictive value and negative predictive value.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cardiac Surgery With Cardiopulmonary Bypass
  • Complete Serum Phosphorus Measure
  • Complete Serum Creatinine Measure
Intervention  ICMJE Other: cardiac surgery
Cohort of patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation
Study Arms  ICMJE Patients having cardiac surgery
Cohort of patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation
Intervention: Other: cardiac surgery
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2016)
264
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All the patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation

Exclusion Criteria:

  • Chronic renal insufficiency with a glomerular filtration rate = 15ml / min / 1.73m2
  • Chronic Renal insufficiency dialysed
  • History of single kidney or nephrectomy
  • Vulnerable people according to the article L1121-6 of the public health Code
  • Protected adult or in the incapacity to give his consent according to the article L1121-8 of the public health Code
  • The patient present formalizes his opposition for the continuation of the study
  • Pregnant or breast-feeding Women according to the article L1121-5 of the Public health Code
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02900313
Other Study ID Numbers  ICMJE UF9585
2015-A00781-48 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marine SAOUR, MD University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP