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Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery

NCT ID: NCT02900313

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery With Cardiopulmonary Bypass Complete Serum Phosphorus Measure Complete Serum Creatinine Measure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

cardiac surgery

Intervention Type OTHER

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

Interventions

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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 Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marine SAOUR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00781-48

Identifier Type: OTHER

Identifier Source: secondary_id

UF9585

Identifier Type: -

Identifier Source: org_study_id