Evidence map›Paper›PMID 32048131›Full record

Trial reportHepatology international2020

Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial.

Rakhi Maiwall, Awinash Kumar, Ajeet Singh Bhadoria, Ankur Jindal, Guresh Kumar, Ankit Bhardwaj, Jaswinder Singh Maras, Manoj Kumar Sharma, Barjesh Chandra Sharma, Shiv Kumar Sarin

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02015403 (TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 33% 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.

NCT02015403 nacompletednot on this map

To compare the efficacy of n -acetylcysteine and standard therapy versus standard therapy in the prevention of ischemic hepatitis and survival post upper gi bleed

TypeinterventionalSponsorInstitute of Liver and Biliary Sciences, IndiaRan2013 to 2015Enrolled220ConditionsIschemic HepatitisArmsStandard Care + NAC (N -ACETYLCYSTEINE), Standard Care (in control arm)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
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

10 authors at 1 institution in 1 country.

Rakhi MaiwallDepartment of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.
Awinash KumarDepartment of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.
Ajeet Singh BhadoriaDepartment of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.
Ankur JindalDepartment of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.
Guresh KumarDepartment of Research, Institute of Liver and Biliary Sciences, New Delhi, India.
Ankit BhardwajDepartment of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.
Jaswinder Singh MarasDepartment of Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
Manoj Kumar SharmaDepartment of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.
Barjesh Chandra SharmaDepartment of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India.
Shiv Kumar SarinDepartment of Hepatology, Institute of Liver and Biliary Sciences, D-1, VasantKunj, New Delhi, 110070, India. shivsarin@gmail.com.ORCID http://orcid.org/0000-0002-0544-5610
Institute of Liver and Biliary Sciences · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsIschemic hepatitis (IH) following acute variceal bleed (AVB) carries an ominous prognosis. N-Acetylcysteine (NAC), a potent anti-oxidant, may prevent IH by improving tissue oxygen delivery and improving hepatic hypoxia.

methodsConsecutive cirrhotics with AVB were prospectively randomized to receive either standard of care (SOC) plus NAC intravenously for 72 h(at 150 mg/kg/h for 1 h followed by 12.5 mg/kg/h for 4 h, followed by 6.25 mg/kg for 67 h) (Group A, n = 107) or SOC alone (Group B, n = 107).

resultsBaseline characteristics were comparable. IH developed more frequently in Gr.B 25(23%) than A-15(14%); p = 0.08). Incidence of IH increased with severity of liver disease. Binary logistic regression analysis showed reduced incidence of IH in Gr.A than B [odds ratio (OR) 0.33, 0.11-0.93] patients after controlling for other significant factors. The incidence of acute kidney injury (AKI) was also reduced in Gr.A [OR 0.34, 0.15-0.75]. Development of IH was significantly associated with increased deaths due to liver failure at 6 weeks [subdistribution hazard ratio (SHR) 21.6, 7.4-62.8]. On multivariate competing risk analysis, significantly lower deaths due to liver failure (SHR 0.33, 0.11-0.97) were noted in Gr.A than B.

conclusionsOne in five patients with acute variceal bleed develops ischemic hepatitis which is associated with worse outcomes. NAC therapy averts deaths due to liver failure by preventing IH and reduces AKI and is, therefore, recommended for cirrhotics with acute variceal bleed.

trial registrationClinicaltrials.gov no: NCT02015403.

Indexed as

HepatitisAcetylcysteineAntioxidantsEsophageal and Gastric VaricesFemaleGastrointestinal HemorrhageGastroscopyHumansInfusions, IntravenousMaleMiddle AgedProspective StudiesTreatment OutcomeAcetylcysteineAntioxidantsAcute kidney injuryAKIAPASL scoreDoor-to-scope timeHypoxic hepatitisInfectionsLactateNACPortal hypertensionShock

Identifiers

PMID32048131
OpenAlexW3005651395

What OpenQuestion holds

Textmetadata
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.