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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
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.
UCHealth - Anschutz Medical Campus
Aurora, Colorado, United States
Percent of patients that complete DPR infusion without reaching stopping criteria
Time frame: Up to 24 hours after initiation of direct peritoneal resuscitation
Rate of return to the operating room after index operation
Amount of patients that require a re-operation after their transplant
Time frame: Up to 7 days after transplant
Abdominal compartment syndrome requiring reoperation
Number of patients that develop increased intraabdominal pressure as a consequence of dialysate infusion
Time frame: Events that occur during the duration of the DPR infusion, which will last no more than 24 hours after the participant's transplant surgery.
Percent of patients that complete DPR infusion
Time frame: Up to 24 hours after initiation of DPR
Percent of patients that are transferred to hospital ward
Patients that are admitted to the hospital ward after surgery, not requiring ICU admission
Time frame: Up to 24 hours after surgery
Rate of early allograft dysfunction
Patients who experience slow function of their transplanted liver after their transplant
Time frame: Up to 7 days after transplant
Number of blood product units required during first 24 hours postoperatively
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.
Time frame: Up to 24 hours after transplant
Number of participants that require renal replacement therapy (i.e. hemodialysis) during the first 7 days after liver transplant.
Researches will record whether the participant developed renal failure requiring renal replacement therapy (i.e. hemodialysis)
Time frame: Up to 7 days after transplant
Hourly urine output for first 24 hours
Time frame: Up to 24 hours after transplant
Rate of early infection after transplant
Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.
Time frame: <7 days postoperatively
Rate of late infection after transplant
Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia.
Time frame: 7-30 days postoperatively
Rate of mechanical bowel obstruction
Constipation caused by compression from inside or outside of the bowel lumen
Time frame: Up to 30 days after transplant
Ileus/time to oral intake
Time to return of normal bowel function and food tolerance after transplant
Time frame: Up to 30 days after transplant
Duration of insulin infusion post-operatively
Insulin requirements after transplant surgery
Time frame: Up to 7 days after transplant
Ventilator free days
Outcome measurement that looks into rate of respiratory failure requiring prolonged mechanical ventilation after transplant surgery
Time frame: Up to 28 days post-op
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