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Refractory AscitesNCT02026609

Glutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)

An observational study of Refractory Ascites and Hepatic Hydrothorax, run by University of Arkansas at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients with cirrhosis and refractory ascites. However, mental changes known as hepatic encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE after TIPS. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Oral glutamine challenge and Psychometric Tests
Type of treatment
Pill or oral medicine
How many people
3 participants
Where
3 sitesin 3 countries
Study dates
May 2013to 27 Jan 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients will be recruited from the Gastroenterology / Hepatology Clinics at UAMS and other participating centers. Those fulfilling inclusion/exclusion criteria will be invited to participate.

Who may be able to join

  • Cirrhosis (any etiology)
  • Refractory ascites or hepatic hydrothorax and plan for TIPS placement

Who cannot join

  • Well-documented overt hepatic encephalopathy, either persistent or at the time of screening
  • Any contraindication for TIPS placement
  • Except for coagulopathy and thrombocytopenia (decided on an individual basis)
  • Uncontrolled depression/anxiety disorder or use of antipsychotic drugs
  • Active use of alcohol or illicit drugs
  • History of dementia
  • TIPS planned for another indication.
  • Active alcoholic liver disease.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

United States1 site

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

Other trials in United States

Canada1 site

  • University of Montreal

    Montreal, Quebec, H2X 1P1

Other trials in Canada

Switzerland1 site

  • University Hospitals of Geneva

    Geneva

Other trials in Switzerland

About this study

Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients with cirrhosis and refractory ascites. However, mental changes known as hepatic encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also predispose patients to HE. The aim of the present study is to assess if both the OGC and psychometric tests can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of HE. The role of muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

Read the detailed description

In cirrhosis, up to 10% of patients develop refractory ascites. TIPS (transjugular intrahepatic portosystemic shunt) is the first-line therapy for these patients. However, 30% will go on to develop hepatic encephalopathy (HE) as a consequence of TIPS, and there is no effective method to predict this outcome. Oral glutamine challenge (OGC) is used to functionally assess ammonia metabolism, and the severity of porto-systemic collateralization, and it has been used to predict overt HE. Psychometric tests (i.e. Psychometric Hepatic Encephalopathy Score [PHES] and inhibitory control test) allow the identification of covert forms of HE and can also predict overt HE. Severe sarcopenia may also predispose patients to HE. The aim of the present study is to assess if both the degree of impairment in ammonia metabolism as estimated with the OGC, and cognitive status as determined by psychometric tests, can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of overt HE. The role of sarcopenia in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

Being tested
Oral glutamine challenge, Psychometric Tests
Keywords
TIPS, Hepatic encephalopathy, Oral glutamine challenge, Psychometric tests, Portal hypertension, Cirrhosis
Medical subject headings
Ascites, Hepatic Encephalopathy, Fibrosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral glutamine challengeOther

    Blood ammonia determination before, 30-, 60-, and 90-minute, after intake of 10 g of L-glutamine

  • Psychometric TestsOther

    PHES (portosystemic hepatic encephalopathy score) and ICT (inhibitory control test)

Study groups in NCT02026609
Study groupRoleWhat they receive
TIPSPatients 18-75 year old with refractory ascites or hepatic hydrothorax and cirrhosis, eligible for TIPS placement. All patients will have a baseline oral glutamine challenge and psychometric tests.
Receives: Other: Oral glutamine challenge; Other: Psychometric Tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overt hepatic encephalopathy

    Classified according to West Haven criteria.

    Measured: up to 18 months

Secondary outcomes (3)

  1. Sarcopenia

    According to CT scan L3 area of muscle mass

    Measured: Baseline and 6 months post-TIPS

  2. Physical activity

    Pedometer readings and physical activity questionnaire

    Measured: Baseline and 6 months post-TIPS

  3. Dietary Intake

    Food frequency questionnaire (FFQ, NutritionQuest, Berkeley, CA)

    Measured: Baseline and 6 months post-TIPS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2014 (estimated)
  2. Study startMay 2013
  3. Primary completion27 Jan 2015
  4. Study completion27 Jan 2015

Why it stopped: Lack of patient accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026609
Sponsor's protocol ID
#135318
Status last verified
Apr 2017
First submitted
26 Dec 2013
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Rossle M, Gerbes AL. TIPS for the treatment of refractory ascites, hepatorenal syndrome and hepatic hydrothorax: a critical update. Gut. 2010 Jul;59(7):988-1000. doi: 10.1136/gut.2009.193227.

    PubMed 20581246

  • Romero-Gomez M, Jover M, Del Campo JA, Royo JL, Hoyas E, Galan JJ, Montoliu C, Baccaro E, Guevara M, Cordoba J, Soriano G, Navarro JM, Martinez-Sierra C, Grande L, Galindo A, Mira E, Manes S, Ruiz A. Variations in the promoter region of the glutaminase gene and the development of hepatic encephalopathy in patients with cirrhosis: a cohort study. Ann Intern Med. 2010 Sep 7;153(5):281-8. doi: 10.7326/0003-4819-153-5-201009070-00002.

    PubMed 20820037

  • Romero-Gomez M, Grande L, Camacho I, Benitez S, Irles JA, Castro M. Altered response to oral glutamine challenge as prognostic factor for overt episodes in patients with minimal hepatic encephalopathy. J Hepatol. 2002 Dec;37(6):781-7. doi: 10.1016/s0168-8278(02)00330-6.

    PubMed 12445419

  • Ditisheim S, Giostra E, Burkhard PR, Goossens N, Mentha G, Hadengue A, Spahr L. A capillary blood ammonia bedside test following glutamine load to improve the diagnosis of hepatic encephalopathy in cirrhosis. BMC Gastroenterol. 2011 Dec 8;11:134. doi: 10.1186/1471-230X-11-134.

    PubMed 22151412

  • Duarte-Rojo A, Estradas J, Hernandez-Ramos R, Ponce-de-Leon S, Cordoba J, Torre A. Validation of the psychometric hepatic encephalopathy score (PHES) for identifying patients with minimal hepatic encephalopathy. Dig Dis Sci. 2011 Oct;56(10):3014-23. doi: 10.1007/s10620-011-1684-0. Epub 2011 Apr 3.

    PubMed 21461913

  • Bajaj JS, Saeian K, Verber MD, Hischke D, Hoffmann RG, Franco J, Varma RR, Rao SM. Inhibitory control test is a simple method to diagnose minimal hepatic encephalopathy and predict development of overt hepatic encephalopathy. Am J Gastroenterol. 2007 Apr;102(4):754-60. doi: 10.1111/j.1572-0241.2007.01048.x. Epub 2007 Jan 11.

    PubMed 17222319

  • Tandon P, Ney M, Irwin I, Ma MM, Gramlich L, Bain VG, Esfandiari N, Baracos V, Montano-Loza AJ, Myers RP. Severe muscle depletion in patients on the liver transplant wait list: its prevalence and independent prognostic value. Liver Transpl. 2012 Oct;18(10):1209-16. doi: 10.1002/lt.23495.

    PubMed 22740290

Questions about this trial

What is this clinical trial studying?

An observational study of Refractory Ascites and Hepatic Hydrothorax, run by University of Arkansas at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of patient accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overt hepatic encephalopathy (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02026609, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.

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