Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

Fresenius Kabi

Status and phase: Completed; Phase 3

Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Treatments: Drug: 1: Hydroxyethyl starch 130/0.4, 6 %

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127477

HE06-008-CP3

Details and patient eligibility

About

The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing major elective surgery
• Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg
• Adult patients: Routine measurement of Central Venous Pressure (CVP)

Exclusion criteria

• Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
• ASA classification ≥ IV
• Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
• Known bleeding disorders
• Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Treatment:

Drug: 1: Hydroxyethyl starch 130/0.4, 6 %