NCT01758172

Brief Summary

From postoperative patients having undergone pancreaticoduodenectomy;

  1. 1.To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven
  2. 2.To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient
  3. 3.To compare the safety of the 2 intravenous colloids in the patient population

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

November 16, 2012

Last Update Submit

January 1, 2013

Conditions

Pancreaticoduodenectomy

Keywords

pancreaticoduodenectomypostoperative patientcolloidalbuminhetastarch

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure

    post-op 24hr

Secondary Outcomes (1)

  • Volume(ml) of colloid

    post-op 24hrs

Study Arms (2)

Albumin

ACTIVE COMPARATOR

albumin was administered to reach CVP up to 7mmHg

Drug: Albumin

6% hydroxyethyl starch 130/0.4

EXPERIMENTAL

6% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg

Drug: 6% hydroxyethyl starch 130/0.4

Interventions

6% hydroxyethyl starch 130/0.4DRUG
6% hydroxyethyl starch 130/0.4
AlbuminDRUG
Albumin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age-from 18-75 years adult
  • In the immediate post-operative period of pancreaticoduodenectomy
  • Written informed consent and admitted ICU immediate post-operative patient

You may not qualify if:

  • Refusal to participate in the study
  • Evidence of pre-operative oliguria (Serum creatinine\>1.5mmol/dL)
  • Known Severe congestive heart failure (NYHAIII,IV)
  • Known severe respiratory diseases (PaO2/FiO2 \<200)
  • Known coagulopathy (Platelet\<100k/mm3, aPTT\>70s, PT(INR)\>2.5)
  • Known allergy to hydroxyethyl starch
  • Known pregnancy or lactation
  • Has participated in any other clinical trial within 3months
  • Any contraindication to Voluven® or albumin according to their package inserts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesAlbumins

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Song-cheol Kim, MD., PhD.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2012

First Posted

January 1, 2013

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

January 1, 2012

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

KR(1)