Direct Peritoneal Resuscitation Plus Conventional Resuscitation

NCT ID: NCT01882218

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-05-31

Brief 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.

Conditions

Hepatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard treatment

Standard liver surgery and post-operative treatment

Group Type: ACTIVE_COMPARATOR

Standard Treatment

Intervention Type: DRUG

Standard liver surgery.

Galactose

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

Group Type: EXPERIMENTAL

Galactose

Intervention Type: DRUG

After surgery, galactose will be dripped into the belly for up to 24 hours after surgery

Interventions

Galactose

After surgery, galactose will be dripped into the belly for up to 24 hours after surgery

Intervention Type: DRUG

Standard Treatment

Standard liver surgery.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Jason Smith

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Smith, MD

Role: PRINCIPAL_INVESTIGATOR

U Louisville

Locations

Norton Hospital

Louisville, Kentucky, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

12.0262

Identifier Type: -

Identifier Source: org_study_id