Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in patients undergoing liver transplantation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

• Aged 18-65 years, male or female

• Elective liver transplantation

• United Network for Organ Sharing (UNOS) Level 2A/B or 3

• Serum albumin ≥ 30 g/L

• Comprehend all the procedures of this study

• Willing and able to give informed consent

Exclusion Criteria:

• Uncontrolled exo-hepatic malignant carcinomas

• Uncontrollable infections (including HIV infection)

• Need support of artificial liver or kidney, ventilator-dependant, coma or unstable hemodynamically

• Patients with a history of hypersensitivity to hydroxyethyl starch or albumin

• Urinary output less than 500 ml within 24 hours after operation

• Patients with intracranial bleeding

• Patients with other colloids for treating hypovolemia

• Patients with pulmonary edema

• Pregnant women or females of childbearing potential and lactating mothers

• Patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the present study