Comparison of Hemodynamic Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

From postoperative patients having undergone pancreaticoduodenectomy;

1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven

2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient

3. To compare the safety of the 2 intravenous colloids in the patient population

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

• Subjects should be meet inclusion criteria to participated into the study

1. Age-from 18-75 years adult

2. In the immediate post-operative period of pancreaticoduodenectomy

3. Written informed consent and admitted ICU immediate post-operative patient

Exclusion Criteria:

• Any patient meeting one or more of the following exclusion criteria may not be entered into the study.

1. Refusal to participate in the study

2. Evidence of pre-operative oliguria (Serum creatinine>1.5mmol/dL)

3. Known Severe congestive heart failure (NYHAIII,IV)

4. Known severe respiratory diseases (PaO2/FiO2 <200)

5. Known coagulopathy (Platelet<100k/mm3, aPTT>70s, PT(INR)>2.5)

6. Known allergy to hydroxyethyl starch

7. Known pregnancy or lactation

8. Has participated in any other clinical trial within 3months

9. Any contraindication to Voluven® or albumin according to their package inserts.