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

Phase 3

Completed

• Conditions: Pancreaticoduodenectomy
• Interventions: Drug: Albumin; Drug: 6% hydroxyethyl starch 130/0.4

• Registration Number: NCT01758172
• Lead Sponsor: Asan Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-10
• Study Completion: 2012-01
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-12-26
• Status Verified: 2013-01
• Study First Posted: 2013-01-01
• Last Update Submitted: 2013-01-01
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin	Albumin	albumin was administered to reach CVP up to 7mmHg
6% hydroxyethyl starch 130/0.4	6% hydroxyethyl starch 130/0.4	6% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure	post-op 24hr

Secondary Outcome Measures

Name	Time	Method
Volume(ml) of colloid	post-op 24hrs

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of