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

University Hospital Center (CHU)

Status: Completed

Conditions: Complete Serum Phosphorus Measure; Cardiac Surgery With Cardiopulmonary Bypass; Complete Serum Creatinine Measure

Treatments: Other: cardiac surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02900313

UF9585

2015-A00781-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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264 participants in 1 patient group

Patients having cardiac surgery

Other group

Description:

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

Treatment:

Other: cardiac surgery