Clinical trial NCT02900313: Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery With Cardiopulmonary Bypass
Complete Serum Phosphorus Measure
Complete Serum Creatinine Measure
Keywords: acute kidney injury
cardiac surgery
cardiac surgery associated acute kidney injury
renal replacement therapy
renal recovery
serum hyperphosphatemia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Dosage of phosphorus
timeFrame: 48 hour after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
Study officials:
affiliation: University Hospital, Montpellier
name: Marine SAOUR, MD
role: PRINCIPAL_INVESTIGATOR
References: