Advertisement

Topics

Efficacy of Combined Oral L-Ornithine-L-Aspartate and Lactulose in Patients With Hepatic Encephalopathy

2014-08-27 03:28:12 | BioPortfolio

Summary

Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial

Description

Data collection

1. Baseline characteristics

- demographic data; age, gender, BW, height

- cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.

- comorbidity such as DM, CVA

2. After randomization

- assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7

- blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7

- record adverse effect of drug such as nausea, vomiting, bloating.

- record diet, frequency of bowel movement and stool pH

- compliance

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hepatic Encephalopathy

Intervention

L-ornithine-L-aspartate and lactulose, placebo and lactulose

Location

Siriraj Hospital, Mahidol University
Bangkok
Thailand
10700

Status

Recruiting

Source

Mahidol University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:28:12-0400

Clinical Trials [665 Associated Clinical Trials listed on BioPortfolio]

Is Continuous Lactulose Therapy Necessary for Patients With Hepatic Encephalopathy? A Study of Controlled Lactulose Withdrawal

After resolution of the initial episode of hepatic encephalopathy (HE), lactulose is routinely continued indefinitely as maintenance therapy. Although widely used for this indication, la...

Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy

The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.

Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy

The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.

Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy

The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.

Efficacy of L-Ornithine-L-Aspartate in Acute Hepatic Encephalopathy

Hepatic encephalopathy is caused by the effects on the brain of substances that under normal circumstances are efficiently metabolized in the liver. The hyperammonemia is the main factor r...

PubMed Articles [2903 Associated PubMed Articles listed on BioPortfolio]

A Randomized Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy.

Hepatic encephalopathy (HE) is a reversible spectrum of neuropsychiatric abnormalities associated with liver dysfunction. Lactulose is a nonabsorbable disaccharide presently used to treat HE. Nitazoxa...

Evaluation of the cost-effectiveness of rifaximin-α for the management of patients with hepatic encephalopathy in the United Kingdom.

Rifaximin-α 550 mg twice daily plus lactulose has demonstrated efficacy in reducing recurrence of episodes of overt HE (OHE) and the risk of HE-related hospitalisations compared with lactulose alon...

A Randomized Controlled Trial Comparing the Efficacy of a Combination of Rifaximin and Lactulose with Lactulose only in the Treatment of Overt Hepatic Encephalopathy.

Hepatic encephalopathy (HE), or portosystemic encephalopathy, represents a reversible decrease in neurologic function caused by liver disease, and treatment has traditionally been with non-absorbable ...

Randomized controlled trial of polyethylene glycol versus lactulose for the treatment of overt hepatic encephalopathy.

Overt hepatic encephalopathy (HE) is a frequent complication of cirrhosis and one of the most debilitating manifestations that necessitates hospitalization. Although many treatment modalities are bein...

Lactulose: a model system to investigate solid state amorphization induced by milling.

In this paper, we show that crystalline lactulose can be amorphized directly in the solid state by mechanical milling. Moreover, compared to similar materials, the amorphization kinetics of lactulose ...

Medical and Biotech [MESH] Definitions

A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)

A urea cycle enzyme that catalyzes the formation of orthophosphate and L-citrulline (CITRULLINE) from CARBAMOYL PHOSPHATE and L-ornithine (ORNITHINE). Deficiency of this enzyme may be transmitted as an X-linked trait. EC 2.1.3.3.

A ureahydrolase that catalyzes the hydrolysis of arginine or canavanine to yield L-ornithine (ORNITHINE) and urea. Deficiency of this enzyme causes HYPERARGININEMIA. EC 3.5.3.1.

An enzyme that catalyzes the conversion of carbamoyl phosphate and L-aspartate to yield orthophosphate and N-carbamoyl-L-aspartate. (From Enzyme Nomenclature, 1992) EC 2.1.3.2.

Substances and drugs that inhibit or block the activity of ORNITHINE DECARBOXYLASE.

More From BioPortfolio on "Efficacy of Combined Oral L-Ornithine-L-Aspartate and Lactulose in Patients With Hepatic Encephalopathy"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Hepatology
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial