Direct Peritoneal Resuscitation Plus Conventional Resuscitation

Sponsor

University of Louisville (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01882218

Collaborator

(none)

Enrollment

Locations

Arms

19.9

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Cancer	Drug: Galactose Drug: Standard Treatment	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Comparison of Direct Peritoneal Resuscitation Plus Conventional Resuscitation Versus Conventional Resuscitation Alone in Patients Undergoing Hepatic Resection for Cancer

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard treatment Standard liver surgery and post-operative treatment	Drug: Standard Treatment Standard liver surgery.
Experimental: Galactose Standard liver surgery with direct peritoneal resuscitation with galactose after surgery.	Drug: Galactose After surgery, galactose will be dripped into the belly for up to 24 hours after surgery

Arm

Intervention/Treatment

Active Comparator: Standard treatment

Standard liver surgery and post-operative treatment

Drug: Standard Treatment

Standard liver surgery.

Experimental: Galactose

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

Drug: Galactose

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

Outcome Measures

Primary Outcome Measures

Morbidity [Six months]

Secondary Outcome Measures

Cytokine levels [Six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norton Hospital	Louisville	Kentucky	United States	40202
2	University of Louisville Hospital	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: Jason Smith, MD, U Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jason Smith, MD, University of Louisville

ClinicalTrials.gov Identifier:

NCT01882218

Other Study ID Numbers:

12.0262

First Posted:

Jun 20, 2013

Last Update Posted:

May 5, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jason Smith, MD, University of Louisville

Liver cancer

Additional relevant MeSH terms:

Liver Neoplasms

Study Results

No Results Posted as of May 5, 2017