Direct Peritoneal Resuscitation Plus Conventional Resuscitation
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | September 2012 |
| End Date: | March 2015 |
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.
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.
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.
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.
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
We found this trial at
2
sites
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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