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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01758172
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pancreaticoduodenectomy	Drug: 6% hydroxyethyl starch 130/0.4; Drug: Albumin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albumin albumin was administered to reach CVP up to 7mmHg	Drug: Albumin
Experimental: 6% hydroxyethyl starch 130/0.4 6% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg	Drug: 6% hydroxyethyl starch 130/0.4

Outcome Measures

Primary Outcome Measures

1. Mean arterial pressure [post-op 24hr]

Secondary Outcome Measures

1. Volume(ml) of colloid [post-op 24hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Song-cheol Kim, MD., PhD., Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Song Cheol Kim, Principal Investigator, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT01758172
• Other Study ID Numbers: 2008-1001
• First Posted: Jan 1, 2013
• Last Update Posted: Jan 3, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Song Cheol Kim, Principal Investigator, Asan Medical Center: pancreaticoduodenectomy; postoperative patient; colloid; albumin; hetastarch
• Additional relevant MeSH terms: Hydroxyethyl Starch Derivatives

Study Results

No Results Posted as of Jan 3, 2013