Effect of Hydroxyethylstarch 6% 130/0.4 Administration on Renal Function After Cardiac Surgery

Not Applicable

Completed

• Conditions: Kidney Function Tests
• Interventions: Other: standard volume therapy; Drug: Hydroxyethylstarch 6% 130/0.4

• Registration Number: NCT02306213
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Recent studies have shown an increased incidence of renal replacement therapy after the use of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However, studies showing detrimental effects of HES have been conducted in mostly non-surgical subjects. There are very few studies analyzing the effects of HES on renal function after cardiac surgery, a population already at risk of renal dysfunction.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-11
• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-28
• Last Update Submitted: 2014-11-28
• Study First Posted: 2014-12-03
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1564

Inclusion Criteria

• All patients undergoing cardiac surgery

Exclusion Criteria

• Heart transplantation
• Ventricular assist devices
• Patients requiring extracorporeal life support before or after cardiac surgery
• Patients revised for bleeding and/or tamponnade presenting with hemodynamic instability
• Patients in whom the administered volume therapy was not completely available
• Subjects who required renal replacement therapy before surgery
• Trauma patients who were put on cardiopulmonary bypass
• Patients who died intra-operatively or soon after arrival in the intensive care unit in whom no postoperative creatinine measurements were available

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Hydroxyethylstarch 6% 130/0.4	standard volume therapy	These patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used.
Hydroxyethylstarch 6% 130/0.4	Hydroxyethylstarch 6% 130/0.4	These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy.
Hydroxyethylstarch 6% 130/0.4	standard volume therapy	These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy.

Primary Outcome Measures

Name	Time	Method
Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.	Up to 45 days

Secondary Outcome Measures

Name	Time	Method
Mortality	Up to 45 days