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

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ClinicalTrials.gov Identifier: NCT01758172
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Song Cheol Kim, 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

Condition or disease Intervention/treatment Phase
Pancreaticoduodenectomy Drug: 6% hydroxyethyl starch 130/0.4 Drug: Albumin Phase 3

Study Type : Interventional  (Clinical Trial)
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 : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: post-op 24hr ]

Secondary Outcome Measures :
  1. Volume(ml) of colloid [ Time Frame: post-op 24hrs ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Song Cheol Kim, Principal Investigator, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01758172     History of Changes
Other Study ID Numbers: 2008-1001
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013

Keywords provided by Song Cheol Kim, Asan Medical Center:
pancreaticoduodenectomy
postoperative patient
colloid
albumin
hetastarch

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes