Direct Peritoneal Resuscitation Plus Conventional Resuscitation

May 2, 2017 updated by: Jason Smith, University of Louisville

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytokine levels
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Jason Smith, MD, U Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (Estimate)

June 20, 2013

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.0262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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