The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS

Portal Hypertension Clinical Trial

Official title:

The Effectiveness of L-ornithine-L-aspartate on Plasma Ammonia in Cirrhotic Patients After TIPS Procedure: a Prospective, Randomized, Controlled, Open-label Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440829
• Other study ID #: LOLA-TIPS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 21, 2011
• Last updated: December 18, 2012
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.

Description:

Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm. Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Cirrhotic patients with refractory ascites or at least one episode of variceal bleeding

• No active bleeding within 5 days before TIPS

• Child-Pugh score = 11

• Signed written informed consent

Exclusion Criteria:

• An age < 18 years or > 65 years

• With TIPS contraindications

• Using drugs for hepatic encephalopathy such as neomycin, rifaximin, lactulose, lactitol or branched-chain amino acid.

• Intake of psychostimulants, sedatives, antidepressants, benzodiazepines or benzodiazepine-antagonists

• Past or present history of hepatic encephalopathy

• Pregnancy or breast-feeding

• Hepatic carcinoma and/or other malignancy diseases

• Sepsis

• Spontaneous bacterial peritonitis

• Uncontrollable hypertension

• Serious cardiac or pulmonary dysfunction

• Renal failure

• Portal vein thrombosis

• History of organ transplantation

• History of HIV (human immunodeficiency viruses) infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Bleeding Varices
• Decompensated Cirrhosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension
• Refractory Ascites

Intervention

Drug:
• L-ornithine-L-aspartate
The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases, Fourth Military Medical University	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Nolte W, Wiltfang J, Schindler C, Münke H, Unterberg K, Zumhasch U, Figulla HR, Werner G, Hartmann H, Ramadori G. Portosystemic hepatic encephalopathy after transjugular intrahepatic portosystemic shunt in patients with cirrhosis: clinical, laboratory, psychometric, and electroencephalographic investigations. Hepatology. 1998 Nov;28(5):1215-25. — View Citation

Rees CJ, Oppong K, Al Mardini H, Hudson M, Record CO. Effect of L-ornithine-L-aspartate on patients with and without TIPS undergoing glutamine challenge: a double blind, placebo controlled trial. Gut. 2000 Oct;47(4):571-4. — View Citation

Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF. L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40. — View Citation

Stauch S, Kircheis G, Adler G, Beckh K, Ditschuneit H, Görtelmeyer R, Hendricks R, Heuser A, Karoff C, Malfertheiner P, Mayer D, Rösch W, Steffens J. Oral L-ornithine-L-aspartate therapy of chronic hepatic encephalopathy: results of a placebo-controlled double-blind study. J Hepatol. 1998 May;28(5):856-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma ammonia	The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.	One week	No
Secondary	Incidence of hepatic encephalopathy		One week	No
Secondary	Liver function	The liver function (includes PT/INR, APTT, albumin, bilirubin, Child-Pugh score) at the first, fourth and seventh days after TIPS procedure.	One week	No
Secondary	Psychometric tests	The results of the psychometric tests (include number connection test A, number connection test B, digit symbol test, serial dotting test, line tracing test) at the first, fourth and seventh days after TIPS procedure.	One week	No