Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery

Cardiac Surgery With Cardiopulmonary Bypass Clinical Trial

— PhosphoIRA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900313
• Other study ID #: UF9585
• Secondary ID: 2015-A00781-48
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: September 29, 2017
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of phosphorus	Kinetic phosphorus during acute renal failure in postoperative cardiac surgery	48 hour after cardiac surgery