- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00308100
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
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 Patients Undergoing Liver Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
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 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 optimized molecular weight and molecule distribution, has a lower degree of substitution (DS) (0.4), and a narrower molecular distribution profile (C2/C6) than other available HES specifications which make it more suitable for volume replacement therapy. Some studies have revealed that Voluven (130/0.4) has a comparable efficacy with HAES-steril (average molecular weight 200.000 dalton, degree of substitution 0.5). Because of its improved pharmacological profile, Voluven (130/0.4) is used to avoid capillary vessel leakage and improve oxygenation of tissues. In addition, Voluven (130/0.4) does not accumulate in plasma or tissues even after multiple dosing (maximal dose 50 ml/kg), and has an improved HES safety profile in terms of coagulation and kidney function.
The current study is designed to assess the efficacy, safety, and pharmaceutical economics characteristic of perioperative volume replacement with Voluven (130/0.4) in patients undergoing liver transplantation compared with patients who received volume therapy with albumin. The objective of this study is to supply appropriate regimens for patients undergoing liver transplantation, considering clinical efficacy, safety, and costs.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100044
- People's Hospital of Peking University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
HES 130/0.4,
administered intra- and perioperatively, max.
daily dose: 33ml/kg BW; if needed, additionally albumin is administered (ratio crystalloid to colloid= 1:1)
Other Names:
|
Active Comparator: 2
|
5% albumin, administered intra- and perioperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemodynamics
Time Frame: From pre-operative period till discharged from hospital
|
From pre-operative period till discharged from hospital
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child-Turcotte-Pugh (CTP) score
Time Frame: From pre-operative period till discharged from hospital
|
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
|
From pre-operative period till discharged from hospital
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xisheng Leng, MD, People's University of Peking University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFP502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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