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

January 1, 2013 updated by: Song Cheol Kim, Asan Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean arterial pressure
Time Frame: post-op 24hr
post-op 24hr

Secondary Outcome Measures

Outcome Measure
Time Frame
Volume(ml) of colloid
Time Frame: post-op 24hrs
post-op 24hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

December 26, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 1, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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