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Peritoneal Resuscitation for Liver Disease
Phase 1
Waitlist Available
Led By Hunter B Moore, M.D., P.hD.
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-30 days postoperatively
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a method that involves putting a special fluid into the belly to reduce swelling and improve blood flow in high-risk liver transplant patients. The goal is to see if this can lower the risk of complications after surgery. This method has been shown to help critically ill trauma patients and organ donors by improving blood flow and reducing inflammation.
Eligible Conditions
- Acute Kidney Failure
- Liver Disease
- Acute Kidney Injury
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-30 days postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-30 days postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Abdominal compartment syndrome requiring reoperation
Duration of insulin infusion post-operatively
Ileus/time to oral intake
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Direct Peritoneal Resuscitation (DPR) GroupExperimental Treatment1 Intervention
At the time of abdominal closure and determination that the patient will either go to extended stay or the intensive care unit, three drains will be placed per standard of care. An additional 19 French drain will be placed at the ligament of Treitz at the base of the mesentery. Following abdominal closure DPR will be initiated with commercially available 2.5% glucose-based peritoneal dialysis solution at a rate of 1.5 cc/kg/hr based on previously reported therapy in trauma. Drains will be connected to continuous wall suction. This infusion will continue for the duration the patients stay in extended stay (8 hours) if they are deemed eligible for hospital ward admission, or for 24 hours if requiring ICU care. These patients will then be observed for their hospital course and monitored for outcomes listed above.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,805 Previous Clinical Trials
2,822,431 Total Patients Enrolled
Hunter B Moore, M.D., P.hD.Principal InvestigatorUniversity of Colorado School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an injury to your diaphragm.You have a severe bacterial infection in your abdomen that has been treated with antibiotics shortly before the surgery.Adults who have had a liver transplant and are 18 years old or older.Your kidney function (creatinine) is not working well before surgery and your body mass index (BMI) is high.
Research Study Groups:
This trial has the following groups:- Group 1: Direct Peritoneal Resuscitation (DPR) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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