Not Yet RecruitingPhase 2ACTRN12612001026819

Bacterial translocation and amelioration of liver cell damage in response to treatment with propranolol, with or without rifaximin, in patients with cirrhosis and portal hypertension


Sponsor

Professor Stephen Riordan

Enrollment

50 participants

Start Date

Oct 1, 2012

Study Type

Interventional

Conditions

Summary

Measurement of the hepatic venous pressure gradient is performed in patients with cirrhosis to assess for portal hypertension and monitor effectiveness of portal venous pressure-lowering therapies. These include treatment with the non-selective beta-blocker, propranolol, while the broad-spectrum antibiotic, rifaximin, has also been shown to be effective. Whether these treatments to reduce portal venous hypertension in patients with cirrhosis are also associated with reduced bacterial translocation from the intestine and whether reduced bacterial translocation, in turn, results in amelioration of liver dameg are currently unknown. The aim of this study is to meaure markers of bacterial translocation and liver damage in patients with portal venous hypertension complicating cirrhosis who are undergoing hepatic venous pressure gradient measurement at baseline and after four weeks of propranolol therapy. Should the portal venous pressure not be improved satisfactorily after treatment with propranolol alone, then rifaximin will be added and the portal venous pressure and markers of bacterial translocation and liver damage will be reassessed after a further 28 days. Patients intolerant of or with contraindications to propranolol will be studied at baseline and after 28 days of rifaximin monotherapy.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria2

  • Cirrhosis
  • Portal hypertension

Exclusion Criteria4

  • Propranolol treatment in the previous three months
  • Antibiotic treatment within the previous three months
  • Hepatocellular carcinoma
  • Inability to give informed consent

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Interventions

All patients will be treated with oral propranolol, 40 mg thrice daily for 28 days. In patients in whom a satisfactory reduction in portal venous hypertension is not achieved at this time point, propr

All patients will be treated with oral propranolol, 40 mg thrice daily for 28 days. In patients in whom a satisfactory reduction in portal venous hypertension is not achieved at this time point, propranolol will be continued at unchanged dose and oral rifaximin, 550 mg twice daily will be added for 28 days. Patients in whom propranolol is either contraindicated or not tolerated will be treated with oral rifaximin monotherapy, 550 mg twice daily for 28 days.


Locations(1)

Australia

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ACTRN12612001026819