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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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, 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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

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