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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Kidney Function Tests

Treatments: Other: standard volume therapy; Drug: Hydroxyethylstarch 6% 130/0.4

Study type: Interventional

Funder types: Other

Identifiers

NCT02306213

Cliniques Universitaires Saint

Details and patient eligibility

About

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.

Enrollment: 1,564 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,564 participants in 2 patient groups

Hydroxyethylstarch 6% 130/0.4

Experimental group

Description:

These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy.

Treatment:

Other: standard volume therapy

Drug: Hydroxyethylstarch 6% 130/0.4

No Hydroxyethylstarch 6% 130/0.4

Active Comparator group

Description:

These patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used.

Treatment:

Other: standard volume therapy