Effect of Preoperative Beta Blocker Use Postoperative Renal Function in the Patients Undergoing Liver Transplantation

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03633812
Collaborator
(none)
477
2
50.1
238.5
4.8

Study Details

Study Description

Brief Summary

This is prospective cohort study of patients classified by the premedication history of beta-blocker. The investigators aim to evaluate the hemodynamic effect of beta blocker through Swan-Ganz catheter monitoring and arterial pressure waveform analysis during surgery. The investigators also plan to observe the long-term effects of beta blocker on acute renal failure, allograft failure and mortality.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational study, Beta blocker medication history

Detailed Description

Since beta blockers have been shown to reduce portal venous pressure in 1980, the nonselective beta blocker (NSBB) has been widely used for the last 25 years as the primary treatment for portal hypertension. NSBB, such as propranolol and nadolol, has been shown to reduce cardiac output through β1 -receptor block and to constrict visceral vessels via β2-receptor block, thereby lowering portal venous pressure in patients with chronic liver disease. NSBB contributed to reducing complications such as esophageal variceal bleeding, ascites, hepatic encephalopathy, and improving survival in patients with cirrhosis. In addition, the use of NSBB in patients with ascites has been demonstrated to reduce the digestion time of intestinal food and reduce bacterial migration into the abdominal cavity and bloodstream.

On the other hand, recent studies have shown that NSBB use in the patients with advanced cirrhosis (accompanied by refractory ascites, spontaneous peritonitis, severe alcoholic hepatitis) may increase circulatory failure, acute renal failure, and mortality. When the cardiac index was less than 1.5 L / min / m² or the mean blood pressure was less than 80 mmHg in advanced cirrhosis with ascites, 1-year survival rate was found to be about 30% lower than the control. The use of beta blockers is argued to be avoided in the cirrhotic patients with refractory ascites because the mortality rate of these patients is associated with the use of beta blockers. These studies have been questioned in terms of reliability of the setting of treatment and control groups and correction of disturbance variables.

The window hypothesis has received attention for the risk-benefit of NSBB. This means that the beta blocker may be beneficial or harmful to the cirrhotic patients depending on the stage of disease progression. In conclusion, the use of beta-blockers in patients with early cirrhosis without moderate to large varix has no effect on prevention of esophageal varices, but is associated with depression, tiredness, sexual dysfunction, decreased cardiac output, increased risk of heart failure, symptomatic bradycardia, increased airway resistance, and bronchospasm. As the cirrhosis progresses, many changes occur in the cardiovascular system. The sympathetic nervous system and resin-angiotensin-aldosterone axis are up-regulated to compensate for the lack of effective blood volume due to peripheral vascular relaxation and hypotension. It is believed that the use of beta-blockers at this time may improve survival by reducing esophageal bleeding and bacterial migration. If the liver cirrhosis progresses more, the use of beta-blockers may compromise cardiac output, blood pressure, perfusion to important organs, thereby increasing the incidence of hepatorenal syndrome and mortality. The use of beta-blockers seems to be beneficial between the point of moderate to large varix generation to the point of advanced cirrhosis with undesired hemodynamic effect (spontaneous ascites, hepatorenal syndrome, spontaneous bacterial peritonitis, sepsis). The research is still ongoing and controversial.

As mentioned earlier, the use of beta blockers in patients with liver disease has been actively studied for the last 10 years, but most studies have been done in patients waiting for liver transplantation. Research is minimal in patients who actually undergo liver transplantation. In addition, studies have shown that beta blockers increase survival in patients waiting for liver transplantation by lowering portal venous pressure through beta 1, 2 -receptor block. But the actual research of preoperative beta blocker on perioperative hemodynamics, postoperative complications, and mortality is still lacking.

This is prospective cohort study of patients classified by the premedication history of beta-blocker. The investigators aim to evaluate the hemodynamic effect of beta blocker through Swan-Ganz catheter monitoring and arterial pressure waveform analysis during surgery. The investigators also plan to observe the long-term effects of beta blocker on acute renal failure, allograft failure and mortality.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
477 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Preoperative Beta Blocker Use on Intraoperative Hemodynamics and Postoperative Renal Function in End-stage Liver Disease Patients Undergoing Liver Transplantation
Actual Study Start Date :
Oct 28, 2016
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Beta blocker group

ESLD recipients who had beta blocker during more than 1 month before the liver transplantation

Other: Observational study, Beta blocker medication history
Observational study, Beta blocker medication history

Non-Beta blocker group

ESLD recipients who had not taken beta blocker more than 3 month before the liver transplantation

Outcome Measures

Primary Outcome Measures

  1. Acute kidney injury [1 week]

    Creatinine change

Secondary Outcome Measures

  1. Graft failure [1 year]

    Graft failure

  2. Mortality [1 year]

    Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • living donor liver transplantation recipients
Exclusion Criteria:
  • previous history of acute kidney injury

  • previous liver transplantation history

  • Fulminant hepatic failure

  • history of TIPS, transjugular intrahepatic porto-systemic shunt

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 05505
2 Asan medical center Seoul Korea, Republic of

Sponsors and Collaborators

  • Asan Medical Center

Investigators

  • Principal Investigator: Jun Gol Song, PH.D., Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jun-Gol Song, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT03633812
Other Study ID Numbers:
  • 2016-1159
First Posted:
Aug 16, 2018
Last Update Posted:
Aug 22, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jun-Gol Song, Professor, Asan Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2018