Evidence map›Paper›PMID 21306407›Full record

GuidelineAlimentary pharmacology & therapeutics2011

Review article: the design of clinical trials in hepatic encephalopathy--an International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) consensus statement.

J S Bajaj, J Cordoba, K D Mullen, P Amodio, D L Shawcross, R F Butterworth, M Y Morgan, International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN)

2 registry-linked trialsOpen access · greenAbstract readConsensus StatementGuidelineReview
In one paragraph

Guideline in Alimentary pharmacology & therapeutics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 153 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
153citing papers in PubMed, 13 pooled it
11.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01722578 phase4completednot on this mapstarted 2013, after this paper: background citation

Efficacy of Intravenous 'L-ornithine L-aspartate' in Reversal of Overt Acute Hepatic Encephalopathy in Patients With Liver Cirrhosis: a Prospective, Randomized, Double-blind, Placebo Controlled Trial

TypeinterventionalSponsorDayanand Medical College and HospitalRan2013 to 2017Enrolled200ConditionsCirrhosis of Liver, Hepatic EncephalopathyArmsL-ornithine L-aspartate, Placebo
NCT04320342 phase3completednot on this mapstarted 2022, after this paper: background citation

A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2022 to 2026Enrolled3,433ConditionsCOPD, COPD ExacerbationArmsBeclomethasone Dipropionate, Glycopyrronium Bromide, Formoterol Fumarate
3 · Its place in the literature

Who cites it

153 citing papers in PubMed, 13 syntheses or guidelines pooled it, 345 citations in OpenAlex.

  1. Pooled it
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  4. Guideline
  5. Guideline
  6. Pooled it
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  10. Branched-chain amino acids for people with hepatic encephalopathy.The Cochrane database of systematic reviews · 2017
    Pooled it
  11. Probiotics for people with hepatic encephalopathy.The Cochrane database of systematic reviews · 2017
    Pooled it
  12. Pooled it
  13. Dopamine agents for hepatic encephalopathy.The Cochrane database of systematic reviews · 2014
    Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

93 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 5 countries.

J S BajajVirginia Commonwealth University and McGuire VA Medical Center, 1201 Broad Rock Boulevard, Richmond, VA 23249, USA. jsbajaj@vcu.edu
J Cordoba
K D Mullen
P Amodio
D L Shawcross
R F Butterworth
M Y Morgan
International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN)
Case Western Reserve University · USHunter Holmes McGuire VA Medical Center · USKing's College School · GBUCL Australia · AUUniversité de Montréal · CAUniversity of Padua · IT

Funding

Spectrum of Neuro-Cognitive Impairment in CirrhosisR01DK087913 · NIDDK · VIRGINIA COMMONWEALTH UNIVERSITY · PI BAJAJ, JASMOHAN S · 2011 to 2015
$2.0M
NIDDK NIH HHS R01 DK087913
6 · The paper itself

Abstract

backgroundThe clinical classification of hepatic encephalopathy is largely subjective, which has led to difficulties in designing trials in this field.

aimsTo review the current classification of hepatic encephalopathy and to develop consensus guidelines on the design and conduct of future clinical trials.

methodsA round table was convened at the 14th International Society for Hepatic Encephalopathy and Nitrogen Metabolism (ISHEN) meeting. Key discussion points were the nomenclature of hepatic encephalopathy and the selection of patients, standards of care and end-points for assessing the treatment and secondary prevention of hepatic encephalopathy.

resultsIt was generally agreed that severity assessment of hepatic encephalopathy in patients with cirrhosis, whether made clinically or more objectively, should be continuous rather than categorical, and a system for assessing the SONIC (Spectrum of Neuro-cognitive Impairment in Cirrhosis) was proposed. Within this system, patients currently classified as having minimal hepatic encephalopathy and Grade I hepatic encephalopathy would be classified as having Covert hepatic encephalopathy, whereas those with apparent clinical abnormalities would continue to be classified as overt hepatic encephalopathy. Some aspects of the terminology require further debate. Consensus was also reached on the patient populations, standards of care and endpoints to assess clinical trial outcomes. However, some compromises had to be made as there is considerable inter- and intravariability in the availability of some of the more objective surrogate performance markers.

conclusionsThe objectives of the round table were met. Robust, defendable guidelines for the conduct of future studies into hepatic encephalopathy have been provided. Outstanding issues are few and will continue to be discussed.

Indexed as

Clinical Trials as TopicHepatic EncephalopathyHumansPatient SelectionResearch DesignSeverity of Illness IndexTerminology as Topic

Identifiers

PMID21306407
PMCPMC3971432
OpenAlexW1486067581

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.