Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant
Condition: Liver Failure
MeSH terms: Liver Failure
Study type: Interventional

Summary: 
      The purpose of this study is evaluate the medication vasopressin for its ability to preserve
      kidney function in patients undergoing liver transplantation.
    

Detailed description: 
      Renal failure is a common complication of liver disease. Hepatorenal syndrome is caused by a
      dysfunctional global circulation in the setting of liver disease: Increased flow to the
      mesenteric circulation is a contributor to decreased blood flow to the kidneys (1). Renal
      failure often worsens in the perioperative period of liver transplantation since the kidneys
      are further stressed by reduced flow due to inferior venacava occlusion, decreased blood flow
      to the kidneys from anesthetics, as well as hypotension from volume shifts, such as when
      large volumes of ascites are removed. Renal failure is a cause of major morbidity and
      mortality in patients undergoing liver transplantation.

      Vasopressin is a logical choice of therapy in this context as the effects of the drug work to
      particularly increase renal blood flow and glomerular filtration rate due to the location of
      specific vasopressin receptors within the renal vasculature. It has been suggested that the
      use of splanchnic (and systemic) vasoconstrictors such as terlipressin (a vasopressin analog)
      or alpha-1-adrenoceptor agonists (midodrine or noradrenaline) may improve renal function in
      patients with type 1 Hepatorenal Syndrome.

      Six studies (with only one randomized study in a small series of patients) have shown that
      terlipressin improves renal function in these patients (2-7). This drug is available in
      Europe, but not in the United States. However, while anesthesiologists commonly use
      vasopressin during liver transplantation in the setting of hepatorenal syndrome or
      vasodilatory shock, the validity of this practice for its effects on renal function and
      outcomes has not been rigorously studied (8-10). Therefore, the purpose of this study is to
      evaluate the effects of low-dose vasopressin on intraoperative and perioperative renal
      function in liver transplant patients.

      This study will be a randomized, double-blind controlled trial performed in adult liver
      transplant patients coming to surgery for chronic liver disease; the major end-points of
      analyses are renal function tests in the perioperative period.
    

Intervention name(s): Vasopressin; Normal saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed; Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: liver transplantation; vasopressin; renal function; hypotension; creatinine; urine output; diuretics; vasopressors; hemodynamic stability