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

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Pancreaticoduodenectomy

Treatments: Drug: Albumin; Drug: 6% hydroxyethyl starch 130/0.4

Study type: Interventional

Funder types: Other

Identifiers

NCT01758172

2008-1001

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Albumin

Active Comparator group

Description:

albumin was administered to reach CVP up to 7mmHg

Treatment:

Drug: Albumin

6% hydroxyethyl starch 130/0.4

Experimental group

Description:

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

Treatment:

Drug: 6% hydroxyethyl starch 130/0.4