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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Function Tests
• Intervention / Treatment: Drug: Hydroxyethylstarch 6% 130/0.4; Other: standard volume therapy

• Study Type: Interventional
• Enrollment (Actual): 1564
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxyethylstarch 6% 130/0.4; These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy.	Drug: Hydroxyethylstarch 6% 130/0.4; Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit; Other Names: Any volume therapy has been recorded; Other: standard volume therapy
Active Comparator: No Hydroxyethylstarch 6% 130/0.4; These patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used.	Other: standard volume therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	Up to 45 days

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: November 28, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: Cliniques Universitaires Saint