Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Surgery With Cardiopulmonary Bypass Acute Kidney Injury Complete Serum Creatinine Measure Complete Serum Phosphorus Measure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Surgery

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

Primary outcomes

Dosage of phosphorus

Time frame: 48 hour after cardiac surgery

Kinetic phosphorus during acute renal failure in postoperative cardiac surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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.

Acronym: PhosphoIRA

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 14, 2016
Registry last updated: Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed