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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

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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery With Cardiopulmonary Bypass Complete Serum Phosphorus Measure Complete Serum Creatinine Measure Other: cardiac surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.
Study Start Date : October 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016

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Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Dosage of phosphorus [ Time Frame: 48 hour after cardiac surgery ]
    Kinetic phosphorus during acute renal failure in postoperative cardiac surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02900313


Locations
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France
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Marine SAOUR, MD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02900313     History of Changes
Other Study ID Numbers: UF9585
2015-A00781-48 ( Other Identifier: ID-RCB )
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Montpellier:
acute kidney injury
cardiac surgery
cardiac surgery associated acute kidney injury
renal replacement therapy
renal recovery
serum hyperphosphatemia