Comparison of Hemodynamic Effects of Two Colloid Therapie... | NCT01758172

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

NCT01758172

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jan 3, 2013Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Pancreaticoduodenectomy

Interventions

6% hydroxyethyl starch 130/0.4
Albumin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2010Actual

Completion Date

Jan 2012Actual

First Submitted Date

Nov 16, 2012

First Submission Date that Met QC Criteria

Dec 26, 2012

First Posted Date

Jan 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2013

Last Update Posted Date

Jan 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

From postoperative patients having undergone pancreaticoduodenectomy;

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
6% hydroxyethyl starch 130/0.4	Drug		6% hydroxyethyl starch 130/0.4
Albumin

Measure	Description	Time Frame
Mean arterial pressure		post-op 24hr

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

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Song-cheol Kim, MD., PhD.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D006895	Hydroxyethyl Starch Derivatives
D000418	Albumins

Ancestor Terms

ID	Term
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans

Browse Leaves

Not provided

Browse Branches

Not provided