NCT01440829

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

September 21, 2011

Last Update Submit

December 18, 2012

Conditions

Decompensated CirrhosisPortal HypertensionBleeding VaricesRefractory Ascites

Keywords

Transjugular Intrahepatic Portosystemic ShuntTIPSLiver CirrhosisLOLAL-ornithine-L-aspartateRefractory Ascites

Outcome Measures

Primary Outcomes (1)

  • Plasma ammonia

    The plasma ammonia concentrations of venous blood at the first, fourth and seventh days after TIPS procedure.

    One week

Secondary Outcomes (3)

  • Incidence of hepatic encephalopathy

    One week

  • Liver function

    One week

  • Psychometric tests

    One week

Study Arms (2)

LOLA group

EXPERIMENTAL

Intervention: LOLA (30g per day) for a week.

Drug: L-ornithine-L-aspartate

Control group

NO INTERVENTION

Patients will not be treated with LOLA.

Interventions

L-ornithine-L-aspartateDRUG

The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.

LOLA group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Related Publications (4)

  • Stauch S, Kircheis G, Adler G, Beckh K, Ditschuneit H, Gortelmeyer R, Hendricks R, Heuser A, Karoff C, Malfertheiner P, Mayer D, Rosch 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. doi: 10.1016/s0168-8278(98)80237-7.

    PMID: 9625322BACKGROUND

  • 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. doi: 10.1002/hep.510300311.

    PMID: 10462368BACKGROUND

  • 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. doi: 10.1136/gut.47.4.571.

    PMID: 10986219BACKGROUND

  • Nolte W, Wiltfang J, Schindler C, Munke 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. doi: 10.1002/hep.510280508.

    PMID: 9794904BACKGROUND

MeSH Terms

Conditions

Hypertension, PortalAscitesLiver Cirrhosis

Interventions

ornithylaspartate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Study Officials

  • Guohong Han, PhD & MD

    Xijing Hospital of Digestive Diseases, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 27, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

CN(1)