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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Song Cheol Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01758172
First received: November 16, 2012
Last updated: January 1, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Pancreaticoduodenectomy
Drug: 6% hydroxyethyl starch 130/0.4
Drug: Albumin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Mean arterial pressure [ Time Frame: post-op 24hr ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Volume(ml) of colloid [ Time Frame: post-op 24hrs ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758172

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Song-cheol Kim, MD., PhD. Asan Medical Center
  More Information

No publications provided

Responsible Party: Song Cheol Kim, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01758172     History of Changes
Other Study ID Numbers: 2008-1001
Study First Received: November 16, 2012
Last Updated: January 1, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
pancreaticoduodenectomy
postoperative patient
colloid
albumin
hetastarch

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014