Norfloxacin for amelioration of portal hypertension in decompensated cirrhosis - a randomized, placebo-controlled, double-blinded clinical trial

Conditions

Portal hypertension, Decompensated cirrhosis

Brief summary

Change in HVPG at 12 weeks compared to baseline in the treatment group as compared to placebo

Detailed description

Incidence of liver-related complications at 12 weeks and at 24 weeks (Spontaneous bacterial peritonitis, Hepatorenal syndrome, Variceal bleeding, Jaundice, Large-volume ascites, Overt hepatic encephalopathy, Any other major infection (pneumonia, sepsis…), Acute-on-chronic liver failure (ACLF), Liver-related death), Liver-related mortality, Biomarkers of bacterial translocation and systemic inflammation at 12 weeks (on-drug) and at 24 weeks (off-drug), Patient-reported outcomes/HRQoL (using validated questionnaires: SF-36 v2.0, CLDQ, FSS) at 12 weeks (on-drug) and at 24 weeks (off-drug), Stool microbiome composition at baseline vs. week 12, Blood metabolomic signatures at baseline vs. week 12

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGFloxacin 400 mg Filmtabletten

DRUGPlacebo consists of gelatine capsules filled with maltodextrin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in HVPG at 12 weeks compared to baseline in the treatment group as compared to placebo	—

Secondary

Measure	Time frame
Incidence of liver-related complications at 12 weeks and at 24 weeks (Spontaneous bacterial peritonitis, Hepatorenal syndrome, Variceal bleeding, Jaundice, Large-volume ascites, Overt hepatic encephalopathy, Any other major infection (pneumonia, sepsis…), Acute-on-chronic liver failure (ACLF), Liver-related death), Liver-related mortality, Biomarkers of bacterial translocation and systemic inflammation at 12 weeks (on-drug) and at 24 weeks (off-drug), Patient-reported outcomes/HRQoL (using validated questionnaires: SF-36 v2.0, CLDQ, FSS) at 12 weeks (on-drug) and at 24 weeks (off-drug), Stool microbiome composition at baseline vs. week 12, Blood metabolomic signatures at baseline vs. week 12	—

Measure

Time frame

Incidence of liver-related complications at 12 weeks and at 24 weeks (Spontaneous bacterial peritonitis, Hepatorenal syndrome, Variceal bleeding, Jaundice, Large-volume ascites, Overt hepatic encephalopathy, Any other major infection (pneumonia, sepsis…), Acute-on-chronic liver failure (ACLF), Liver-related death), Liver-related mortality, Biomarkers of bacterial translocation and systemic inflammation at 12 weeks (on-drug) and at 24 weeks (off-drug), Patient-reported outcomes/HRQoL (using validated questionnaires: SF-36 v2.0, CLDQ, FSS) at 12 weeks (on-drug) and at 24 weeks (off-drug), Stool microbiome composition at baseline vs. week 12, Blood metabolomic signatures at baseline vs. week 12

—

Countries

Austria

Outcome results

None listed