Status:
COMPLETED
Study to Evaluate the Effect of Hydroxyethyl Starch (HES) in Complications of Patients After Abdominal Surgery
Lead Sponsor:
Fresenius Kabi
Conditions:
Postoperative Complications
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT00308126
Start Date
June 1 2005
End Date
September 1 2006
Last Update
December 11 2007
Active Locations (1)
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1
Peking Union Medical College (PUMC) Hospital
Beijing, China, 100730