Study to Evaluate the Effect of Hydroxyethyl Starch (HES) in Complications of Patients After Abdominal Surgery

December 7, 2007 updated by: Fresenius Kabi

Phase IV, Open-Label, Randomized, Albumin-Controlled, Parallel Group, Multicenter Study to Evaluate the Effect of Medium Molecule HES (130/0.4) in Complications for Patients After Abdominal Surgery

Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups

Study Design: Open-label, active controlled, parallel group, randomized, multi-center study. Per protocol, 624 patients required in 6 study centers.

Hypothesis: No difference in rate of postoperative (post-op) complications between HES and albumin groups

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since the application of surgical operations, postoperative complications have been the area surgeons explored the most. Though surgical technological advances make it possible for most patients to recover from an operation, the prevention and management of the postoperative complications are still important for surgeons.

Traditionally, the level of albumin is an important marker for the prognosis of the patient. When the level of albumin is below 35 g/L, the mortality rate and other complications will increase significantly, so albumin has become the widely used colloid liquid in fluid therapy for postoperative patients. Actually, the body cannot utilize exogenous albumin and it takes 6-7 days for the body to synthesize new albumin. There is dispute concerning whether albumin should be used in postoperative treatments for severely ill patients. The well-known SAFE study found there was no difference in the efficacy between albumin and crystalloids for severe patients in the 28-day observation time. A meta analysis of 24 studies involving 1419 patients came to the conclusion that administration of albumin could increase the mortality rate in patients. The high price of albumin is another target for extensive criticism.

On the other hand, maintaining colloid osmotic pressure at a certain level in the circulatory system is essential for postoperative patients to stabilize hemodynamics, reduce tissue edema, improve recovery, so it is beneficial for patients to replace albumin with Voluven (130/0.4). Voluven (130/0.4) is a medium-molecular-weight hydroxyethyl starch produced by Fresenius Kabi Pharmaceutical Co. Ltd, and is widely used clinically in volume replacement therapy. Its efficacy and safety are proved by its clinical practices, however, its effect in patients with postoperative complications is not clear. The study will compare the effect of Voluven (130/0.4) and albumin on the occurrence of postoperative complications in patients with an abdominal operation to provide guidance on selection of safe and economic volume replacement therapy for postoperative patients.

STUDY OBJECTIVES

To compare the effect of Voluven (130/0.4) to that of albumin for occurrence of postoperative complications in patients with abdominal surgery from the day of the operation to 28th day after the operation.

Study Type

Interventional

Enrollment

624

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Peking Union Medical College (PUMC) Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 18 to 75, male or female
  • After abdominal operation of medium scale or above (including but not limited to: gastric cancer eradication, rectal cancer eradication, hepatic lobectomy, corpus and cauda pancreatectomy)
  • Hemoglobin (Hb) no less than 70g/L; serum albumin no less than 30 g/L before operation
  • Blood loss during operation no more than 2000 ml

Exclusion Criteria:

  • Known to be allergic to HES or albumin
  • Urine output less than 500 ml/24 hours
  • Intra-cranial hemorrhage
  • Liver transplantation
  • Use colloid other than study drugs
  • Lung edema
  • Pregnant, lactating female
  • Participate in other clinical study within 30 days
  • Poor compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Occurrence of any postoperative complication stipulated in protocol within 28 days after abdominal operation

Secondary Outcome Measures

Outcome Measure
28th day after abdominal operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

  • Principal Investigator: Yupei Zhao, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 29, 2006

Study Record Updates

Last Update Posted (Estimate)

December 11, 2007

Last Update Submitted That Met QC Criteria

December 7, 2007

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFP501

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.

Clinical Trials on Postoperative Complications

Clinical Trials on Hydroxyethyl Starch 130/0.4 (Voluven)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe