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OpenTrials
Completed

NCT Number: NCT01758172

Comparison of Hemodynamic 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

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Key information

Conditions

Pancreaticoduodenectomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects should be meet inclusion criteria to participated into the study
  • Age-from 18-75 years adult
  • In the immediate post-operative period of pancreaticoduodenectomy
  • 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.
  • 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.

Treatment and study plan

6% hydroxyethyl starch 130/0.4

Drug

ALBUMIN

Drug

Primary outcomes

  1. Mean arterial pressure

    Time frame: post-op 24hr

Secondary outcomes

  1. Volume(ml) of colloid

    Time frame: post-op 24hrs

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Jan 1, 2013
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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