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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pancreaticoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Albumin

albumin was administered to reach CVP up to 7mmHg

Group Type ACTIVE_COMPARATOR

Albumin

Intervention Type DRUG

6% hydroxyethyl starch 130/0.4

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

Group Type EXPERIMENTAL

6% hydroxyethyl starch 130/0.4

Intervention Type DRUG

Interventions

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6% hydroxyethyl starch 130/0.4

Intervention Type DRUG

Albumin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No