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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758172

Enrollment

100

Registered

2013-01-01

Start date

2009-10-31

Completion date

2012-01-31

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy

Keywords

pancreaticoduodenectomy, postoperative patient, colloid, albumin, hetastarch

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

Interventions

DRUG6% hydroxyethyl starch 130/0.4

DRUGAlbumin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean arterial pressure	post-op 24hr

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026