Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This investigational trial will be assessing the effect of rifaximin on pathophysiology and haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on several organs on marker level. The molecular and physiological effects of rifaximin will be explored.

The investigators hypothesize that intestinal decontamination with rifaximin in patients with cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the following inflammatory response, prevent splanchnic vasodilatation and portal systemic contraction and thereby reduce the risk clinical complications to cirrhosis.

If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement in liver haemodynamics, renal function and systemic dynamics, then these effects may contribute to the overall well-being of the patient and prevent complications to the underlying cirrhosis such as risk of infections, progression of disease, and admission to hospital.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: Norgine; Region MidtJylland Denmark; Statens Serum Institut
• Treatments: Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Decompensated liver cirrhosis and clinical signs of ascites

• Age 18 - 80 years

• Portal hypertension and hepatic venous pressure gradient (HVPG) of 10 mmHg or more

• Women of child-bearing age must use safe anticonception, either hormonal anticonception or intrauterine device (IUD)

Exclusion Criteria:

• Child-Pugh score above 12

• Clinical signs of infection or biochemical signs of infection with leucocytes > 10x10'9/L and C-Reactive Protein (CRP)> 20 or positive urine culture

• Hepatocellular carcinoma within the last year

• Invasive cancer within the last five years

• Hepatic encephalopathy above grade 1

• serum creatinine > 200 micromoles/L

• Transfusion requiring bleeding one week prior to inclusion

• severe cardiac, pulmonary or kidney disease or IDDM

• alcohol abuse and symptoms of abstinences

• Expected survival less than 3 months

• Denied consent