Evidence map›Paper›PMID 32739495›Full record

ArticleContemporary clinical trials2020

Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis.

Srinivasan Dasarathy, Mack C Mitchell, Bruce Barton, Craig J McClain, Gyongyi Szabo, Laura E Nagy, Svetlana Radaeva, Arthur J McCullough

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
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  10. Therapeutic Perspectives of IL1 Family Members in Liver Diseases: An Update.Journal of clinical and translational hepatology · 2022
    Review
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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 1 country.

Srinivasan DasarathyCleveland Clinic, USA. Electronic address: dasaras@ccf.org.
Mack C MitchellUniversity of Texas at Southwestern University, USA.
Bruce BartonUniversity of Massachusetts, USA.
Craig J McClainUniversity of Louisville, USA.
Gyongyi SzaboHarvard Medical School & Beth Israel Deaconess Medical Center, USA.
Laura E NagyCleveland Clinic, USA.
Svetlana RadaevaNational Institute of Alcohol Abuse and Alcoholism, USA.
Arthur J McCulloughCleveland Clinic, USA.
Cleveland Clinic · USBeth Israel Deaconess Medical Center · USNational Institute on Alcohol Abuse and Alcoholism · USSouthwestern University · USUniversity of Louisville · USUniversity of Massachusetts Boston · US

Funding

Project Two - Exercise Training Decreases Alcohol Drinking by an FGF21-Dependent MechanismP50AA024333 · NIAAA · CLEVELAND CLINIC LERNER COM-CWRU · PI LAURA E. NAGY · 2016 to 2026
$19.6M
Non Alcoholic Steatohepatitis Clinical Research NetworkU01DK061732 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI Srinivasan Dasarathy · 2002 to 2026
$12.2M
Novel Therapies for Alcoholic HepatitisU01AA021893 · NIAAA · CLEVELAND CLINIC LERNER COM-CWRU · PI MCCLAIN, CRAIG J., MCCULLOUGH, ARTHUR JOSEPH · 2012 to 2017
$6.0M
Integrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD)- Cleveland Clinic Clinical CenterU01AA026976 · NIAAA · CLEVELAND CLINIC LERNER COM-CWRU · PI Srinivasan Dasarathy, David Streem · 2018 to 2026
$3.2M
Integrated therapies for alcohol use and ALD (ITAALD) Network -UofL Clinical CenterU01AA026980 · NIAAA · UNIVERSITY OF LOUISVILLE · PI CRAIG J. MCCLAIN, Ashwani K Singal · 2018 to 2026
$2.9M
Sarcopenia in cirrhosis is mediated by a hyperammonemic stress responseR01DK113196 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI DASARATHY, SRINIVASAN, HATZOGLOU, MARIA · 2018 to 2021
$2.3M
Mechanisms of Malnutrition in Cirrhosis with Portosystemic ShuntingR01DK083414 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI DASARATHY, SRINIVASAN · 2011 to 2015
$1.8M
Microbial metabolites and Innate Immunity in AH: Biomarkers of injury and repairU01AA026938 · NIAAA · CLEVELAND CLINIC LERNER COM-CWRU · PI NAGY, LAURA E. · 2018 to 2023
$1.4M
Mechanisms of Malnutrition in Cirrhosis with Portosystemic ShuntingR01GM119174 · NIGMS · CLEVELAND CLINIC LERNER COM-CWRU · PI DASARATHY, SRINIVASAN · 2017 to 2020
$1.2M
Hyperammonemia reduces skeletal muscle protein synthesis via a beta-catenin-cMyc mediated impaired ribosomal biogenesisR21AR071046 · NIAMS · CLEVELAND CLINIC LERNER COM-CWRU · PI DASARATHY, SRINIVASAN, DAVULURI, GANGARAO · 2017 to 2018
$399k
NIAAA NIH HHS P50 AA024333NIAAA NIH HHS U01 AA021893NIAAA NIH HHS U01 AA026938NIAAA NIH HHS U01 AA026976NIAAA NIH HHS U01 AA026980NIAMS NIH HHS R21 AR071046NIDDK NIH HHS R01 DK083414NIDDK NIH HHS R01 DK113196NIDDK NIH HHS U01 DK061732NIGMS NIH HHS R01 GM119174
6 · The paper itself

Abstract

BACKGROUND/

aimsDespite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH.

methodsSevere AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score ≥ 20 stratified by MELD scores (20-25 and ≥ 26) and randomized to a combination of an interleukin receptor 1 antagonist, Anakinra(100 mg daily for 14 days) to suppress acute inflammation, pentoxifylline (400 mg three times a day for 28 days) to prevent hepatorenal syndrome, and zinc sulfate (220 mg orally once daily for 6 months) or the standard of care therapy including methylprednisolone 32 mg orally once daily for 28 days. The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.

resultsBetween July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6 ± 3.2 (20.0-35.0) in the investigational arm and 25.8 ± 4.5 (20.0-40.0) in the standard of care arm. Causes of screen failures included not meeting eligibility criteria (n = 347), declining to participate (n = 39), and other reasons (n = 10).

conclusionsData from the DASH consortium studies will determine if a combination of drugs targeting multiple mechanisms of injury in the severe AH will improve clinical outcomes.

Indexed as

End Stage Liver DiseaseFatty Liver, AlcoholicHepatitis, AlcoholicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment Outcome

Identifiers

PMID32739495
PMCPMC7494528
OpenAlexW3046828453

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Registered trials

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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.