Direct Peritoneal Resuscitation Plus Conventional Resuscitation

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 4

Conditions: Hepatic Cancer

Treatments: Drug: Galactose; Drug: Standard Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01882218

12.0262

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Standard treatment

Active Comparator group

Description:

Standard liver surgery and post-operative treatment

Treatment:

Drug: Standard Treatment

Galactose

Experimental group

Description:

Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.

Treatment:

Drug: Galactose