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

Kidney Function Tests Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306213
• Other study ID #: Cliniques Universitaires Saint
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: November 28, 2014
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2014
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1564
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Function Tests

Intervention

Drug:
• Hydroxyethylstarch 6% 130/0.4
Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit

Other:
• standard volume therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria.		Up to 45 days	No
Secondary	Mortality		Up to 45 days	No