Direct Peritoneal Resuscitation Plus Conventional Resuscitation
Conditions
Hepatic Cancer
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Liver cancer
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Galactose Type: Drug
Name: Standard Treatment Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to find out if direct peritoneal resuscitation (DPR) (putting a sugar solution into the abdominal cavity) helps blood flow through vital organs in the body that may suffer from low blood flow due to surgery. We will also try to find out if the DPR will help patients recover faster from liver surgery. Lastly, this study will also try to find if direct peritoneal resuscitation decreases levels of signaling chemicals in the blood called 'cytokines' and a protein called high-mobility group protein 1, which is known to cause tissue damage.
Detailed Description
Our study will focus on 108 patients requiring hepatic resection for colorectal cancer metastasis or primary hepatocellular carcinoma. These patients will then be randomized into two 54 patient arms: the control arm of conventional resuscitation only and the experimental arm of conventional resuscitation with DPR immediately post operatively. Patient exclusion criteria will be: 1) unable to obtain proper consent for enrollment, 2) age less than 18 years or greater than 75 years, 3) chronic renal failure, cirrhosis, or congestive heart failure, 4) patients requiring portal venous embolization prior to resection, or 5) women who are pregnant or lactating/breast feeding. A pregnancy test (urine or blood) will be done for female subjects of child bearing potential the day prior or the morning of surgery per the usual standard of care pre-op labs.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Colorectal cancer

- Scheduled for liver resection

- 18 to 75

Exclusion Criteria:

- Chronic renal failure

- Cirrhosis

- Congestive heart failure

- Requiring portal venous embolization prior to resection

- Pregnant or nursing
Locations
Norton Hospital
Louisville, Kentucky, United States
Status: Recruiting
Contact: Jason Smith, MD - 502-852-5675 - j0smit19@louisville.edu
University of Louisville Hospital
Louisville, Kentucky, United States
Status: Recruiting
Contact: Jason Smith, MD - 502-852-1895 - j0smit19@louisville.edu
Start Date
September 2012
Completion Date
March 2015
Sponsors
University of Louisville
Source
University of Louisville
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page