Acute Kidney Injury, End Stage Liver DIsease, Obesity
Conditions
Keywords
Liver transplant, Obesity, Renal failure
Brief summary
This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreciated in other surgical patients. The combination of elevated BMI and impaired kidney function increases the risk of 1) needing intensive care unit (ICU) admission after surgery, 2) slow function of the new liver \[technically termed Early Allograft Dysfunction (EAD)\] and 3) need for more than one operation. The study team also aims to identify if DPR can reduce these risks and not cause other unexpected complications following surgery. DPR involves the infusion of a solution into the abdomen and has been shown to reduce edema and improve blood flow in organs. The solution used in this study is a commercially available peritoneal dialysate, a dextrose containing solution that is infused into the abdominal cavity and is routinely used in patients with end-stage renal disease requiring dialysis.
Detailed description
The central hypothesis of this study is that direct peritoneal resuscitation is a safe therapy following liver transplantation and is associated with a reduced rate of return to the operating room. AIM 1: Determine the safety profile of direct peritoneal resuscitation on liver transplant recipients at risk of return to the operating room and ICU admission. Hypothesis: Liver transplant recipients that receive DPR will have comparable complication rates to historic controls of liver transplant recipients with similar demographics. AIM 2: Identify if direct peritoneal resuscitation demonstrates a trend towards a reduced rate of return to the operating room compared to historic controls. Hypothesis: DPR will demonstrate a trend of a reduce rate of return to the operating room of liver transplant patients after index operation compared to historic controls. AIM 3: Identify if direct peritoneal resuscitation reduces the rate of early allograft dysfunction and other organ failure following liver transplantation with interval improvement in post-operative fibrinolysis activity. Hypothesis: DPR will reduce the rate of EAD of liver transplant patients compared to historic controls and is associated with increased fibrinolysis in the post-operative period.
Interventions
PROCEDUREDirect Peritoneal Resuscitation
Direct peritoneal resuscitation involves the abdominal infusion and drainage of a peritoneal dialysate in high-risk liver transplant patients, for up to 24 hours after surgery.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All study subjects will be enrolled to the treatment arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult liver transplant recipients ≥18 y/o * Ability to consent * Pre-operative Creatinine ≥1.1 (or on dialysis) and BMI ≥30
Exclusion criteria
* Diaphragmatic injury * Active spontaneous bacterial peritonitis (SBP) with initiation of antibiotic treatment within 72 hours of surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients that complete DPR infusion without reaching stopping criteria | Up to 24 hours after initiation of direct peritoneal resuscitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal compartment syndrome requiring reoperation | Events that occur during the duration of the DPR infusion, which will last no more than 24 hours after the participant's transplant surgery. | Number of patients that develop increased intraabdominal pressure as a consequence of dialysate infusion |
| Percent of patients that complete DPR infusion | Up to 24 hours after initiation of DPR | — |
| Percent of patients that are transferred to hospital ward | Up to 24 hours after surgery | Patients that are admitted to the hospital ward after surgery, not requiring ICU admission |
| Rate of early allograft dysfunction | Up to 7 days after transplant | Patients who experience slow function of their transplanted liver after their transplant |
| Number of blood product units required during first 24 hours postoperatively | Up to 24 hours after transplant | The study team will record the number of units of blood product (i.e. bags of red blood cells, platelets, etc.) required by the participant in the first day after liver transplantation. |
| Number of participants that require renal replacement therapy (i.e. hemodialysis) during the first 7 days after liver transplant. | Up to 7 days after transplant | Researches will record whether the participant developed renal failure requiring renal replacement therapy (i.e. hemodialysis) |
| Rate of return to the operating room after index operation | Up to 7 days after transplant | Amount of patients that require a re-operation after their transplant |
| Rate of early infection after transplant | <7 days postoperatively | Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia. |
| Rate of late infection after transplant | 7-30 days postoperatively | Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia. |
| Rate of mechanical bowel obstruction | Up to 30 days after transplant | Constipation caused by compression from inside or outside of the bowel lumen |
| Ileus/time to oral intake | Up to 30 days after transplant | Time to return of normal bowel function and food tolerance after transplant |
| Duration of insulin infusion post-operatively | Up to 7 days after transplant | Insulin requirements after transplant surgery |
| Ventilator free days | Up to 28 days post-op | Outcome measurement that looks into rate of respiratory failure requiring prolonged mechanical ventilation after transplant surgery |
| Hourly urine output for first 24 hours | Up to 24 hours after transplant | — |
Countries
United States
Outcome results
None listed