Status:
TERMINATED
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
Lead Sponsor:
Fresenius Kabi
Conditions:
Intraoperative Complications
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 replace...
Detailed Description
End-stage liver disease is one of the major diseases leading to death. With advancement of transplantation surgery and perioperative anesthesia management, liver transplantation has become an effectiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00308100
Start Date
October 1 2005
End Date
July 1 2008
Last Update
January 15 2009
Active Locations (1)
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1
People's Hospital of Peking University
Beijing, China, 100044