Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery

NCT02900313 | Completed DMC

• 2 other identifiers: UF95852015-A00781-48
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Dosage of phosphorus

  Kinetic phosphorus during acute renal failure in postoperative cardiac surgery

  48 hour after cardiac surgery

Study Arms (1)

Patients having 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

Other: cardiac surgery

Interventions

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

Patients having cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Marine SAOUR, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 14, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 3, 2017

Record last verified: 2015-06

Locations

FR (1)