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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
History of Changes
  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:

Drug Information available for: Hetastarch
U.S. FDA Resources

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
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:
Hetastarch
Plasma Substitutes
Blood Substitutes
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013