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

NCT00308100 | Terminated Phase 4 DMC

• 1 other identifier: BFP502
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Complications

Keywords

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Hemodynamics

  From pre-operative period till discharged from hospital

Secondary Outcomes (2)

• Child-Turcotte-Pugh (CTP) score

  From pre-operative period till discharged from hospital

• Model for End-Stage Liver Disease (MELD) score

  From pre-operative period till discharged from hospital

Study Arms (2)

1

EXPERIMENTAL

Drug: Hydroxyethylstarch 130/0.4

2

ACTIVE COMPARATOR

Drug: 5% Albumin

Interventions

Hydroxyethylstarch 130/0.4 DRUG

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)

Also known as: HES 130/0.4, Hydroxyethyl starch 130/0.4

1

5% Albumin DRUG

5% albumin, administered intra- and perioperatively

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (1)

People's Hospital of Peking University

Beijing, 100044, China

Location

MeSH Terms

Conditions

Intraoperative Complications

Interventions

Hydroxyethyl Starch Derivatives; Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Xisheng Leng, MD

  People's University of Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 29, 2006
• Study Start: October 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 15, 2009

Record last verified: 2009-01

Locations

CN (1)