Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01758172
Other study ID # 2008-1001
Secondary ID
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 VoluvenĀ® 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


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
See also
  Status Clinical Trial Phase
Completed NCT00827931 - Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Major Abdominal Surgery Phase 4
Completed NCT05567094 - The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy Phase 4
Recruiting NCT05523713 - Development and Validation of a Predictive Score for Surgical Site Infections Phase 3
Completed NCT01988519 - Randomized Controlled Trial Comparing Closed-suction Drain Versus Passive Gravity Drain Following Pancreatic Resection N/A
Recruiting NCT04118881 - Ear Acupuncture Preventing Delayed Gastric Emptying. N/A
Recruiting NCT04798560 - Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
Recruiting NCT04559269 - Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests
Recruiting NCT06119880 - The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy Phase 4
Not yet recruiting NCT05389917 - Three-Dimensional Vascular Reconstruction of the Pancreas on Multidetector Computed Tomography Images and Its Impact on Patients Undergoing Pancreaticoduodenectomy
Completed NCT02807701 - Minimally Invasive Pancreatico-duodenectomy N/A
Recruiting NCT01428050 - The Use of a Restrictive Fluid Regimen With Hypertonic Saline for Patients Undergoing Pancreaticoduodenectomy Phase 2
Completed NCT00668876 - Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy Phase 4
Recruiting NCT06322680 - Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy N/A
Not yet recruiting NCT05314244 - Comparison Between Pylorus-resecting and Preserving Pancreaticoduodenectomy on Delayed Gastric Emptying and Nutrition N/A
Not yet recruiting NCT06123169 - Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent Phase 3
Completed NCT00931554 - Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections N/A
Completed NCT00200148 - Acute Normovolemic Hemodilution Versus Standard Intraoperative Management in Patients Having Hepatic Resection and Pancreaticoduodenectomy Phase 3
Recruiting NCT04342923 - Early POstoperative BIomarkers in PancreatoDuodenectomy: a Spanish Nationwide Study
Recruiting NCT03785743 - Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma N/A
Completed NCT03791450 - Investigation of Pancreaticoduodenectomy