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

Pancreaticoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758172
• Other study ID #: 2008-1001
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2012
• Last updated: January 1, 2013
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Intervention

Drug:
• 6% hydroxyethyl starch 130/0.4

• Albumin

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure		post-op 24hr	Yes
Secondary	Volume(ml) of colloid		post-op 24hrs	No