VolulyteTM in Cardiac Surgery

Fresenius Kabi

Status and phase: Completed; Phase 4

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery

Treatments: Drug: Human serum albumin; Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01553617

VOLU-010-C P4

Details and patient eligibility

About

The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female adult patients
• undergoing primary elective cardiac surgery applying extracorporeal circulation
• signed written informed consent

Exclusion criteria

• known contraindication against scheduled medication
• pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
• planned systemic hypothermia (body temperature < 30°C)
• expected time on ECC ≥ 2 hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

133 participants in 2 patient groups

Volulyte

Experimental group

Description:

6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)

Treatment:

Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)

Human serum albumin

Active Comparator group

Description:

Human serum albumin (HSA 50g/L)

Treatment:

Drug: Human serum albumin