Study to Evaluate the Effect of Hydroxyethyl Starch (HES) in Complications of Patients After Abdominal Surgery
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): Hydroxyethyl Starch 130/0.4 (Voluven)
Intervention type(s): Drug
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abdominal operation