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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicenter, Randomized, Open-Label, Parallel-Group, Albumin-Controlled Phase IV Study to Evaluate the Efficacy and Safety of Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Patien

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 replacement with Voluven (Hydroxyethyl starch 130/0.4) and albumin in patients undergoing liver transplantation.

Detailed Summary:

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 effective method to recover patients' liver function, thus saving their lives and improving their quality of life. Serious disorders of fluid balance, such as blood coagulation dysfunction, electrolyte disequilibrium, hypoalbuminaemia, low hematocrit, low hemoglobin and acid-base imbalance etc. exist in end stage cirrhosis patients with liver transplantation. Such abnormalities in the internal milieu could cause or worsen cardiovascular and pulmonary dysfunction, thus making perioperative management more difficult.

Albumin and blood plasma are conventionally used as plasma volume expanders in clinical practice. At the same time, the level of albumin concentration is also used as an important criterion of prognosis. When the level of albumin concentration in serum is below 35 g/L, postoperative mortality rates and complications will increase significantly. In fact, it has been the focus of debate for many years whether albumin should be used for volume replacement in critically ill patients. Boldt and his colleagues demonstrated that albumin has little positive influence on the prognosis of critically ill patients. However, Shwe deemed albumin beneficial to critically ill patients. Simon suggested that albumin is given mainly for treating hypovolemia instead of increasing the level of albumin concentration in serum. However, at the same time, he admitted there is no advantages of albumin in comparison to other colloid solutions and, furthermore, it is more expensive.

Voluven (130/0.4) is a medium molecular weight hydroxyethyl starch (HES) produced by Beijing Fresenius Kabi Pharmaceutical Co., Ltd. It is a novel HES preparation with opt
Sponsor: Fresenius Kabi

Current Primary Outcome: Hemodynamics [ Time Frame: From pre-operative period till discharged from hospital ]

Original Primary Outcome: Hemodynamics,

Current Secondary Outcome:

  • Child-Turcotte-Pugh (CTP) score [ Time Frame: From pre-operative period till discharged from hospital ]
  • Model for End-Stage Liver Disease (MELD) score [ Time Frame: From pre-operative period till discharged from hospital ]


Original Secondary Outcome:

  • CTP
  • MELD


Information By: Fresenius Kabi

Dates:
Date Received: March 28, 2006
Date Started: October 2005
Date Completion:
Last Updated: January 14, 2009
Last Verified: January 2009