Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Phase 4 Completed 88 enrolled Hospital General de Mexico

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The aim of this study is to determine whether lactulose, L-ornithine L-aspartate, and rifaximin are effective in the prevention of the development of hepatic encephalopathy in cirrhotic patients with acute variceal bleeding

Timeline

Start: 2014-07
Primary completion: 2016-06
Completion: 2016-06

Outcome

Mixed primary results

paper lactulose (54.5% versus 27.3%; OR = 0.3, 95% CI 0.09-1.0; P = 0.06) PMID 30079329 ↗

paper L-ornithine L-aspartate (54.5% versus 22.7%, OR = 0.2, 95% CI 0.06-0.88; P = 0.03) PMID 30079329 ↗

paper rifaximin (54.5% versus 23.8%; OR = 0.3, 95% CI 0.07-0.9; P = 0.04) PMID 30079329 ↗

Publications

Higuera-de-la-Tijera F, Servin-Caamano AI, Salas-Gordillo F, Perez-Hernandez JL, Abdo-Francis JM, Camacho-Aguilera J, Alla SN, Jimenez-Ponce F. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018 Jul 10;2018:3015891. doi: 10.1155/2018/3015891. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	L-ornithine L-aspartate	Other / unclassified	10 g	Intravenous
Subject	Lactulose	Other / unclassified	30 ml	Oral
Subject	Rifaximin	Other / unclassified	400 mg	—