Evidence map›Paper›PMID 38727780›Full record

Trial reportHepatology international2024

Midodrine plus propranolol versus propranolol alone in preventing first bleed in patients with cirrhosis and severe ascites: a randomized controlled trial.

Abhijeet Ranjan, Ankur Jindal, Rakhi Maiwall, Chitranshu Vashishtha, Rajan Vijayaraghavan, Vinod Arora, Shiv K Sarin

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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

8 citing papers in PubMed.

  1. 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

7 authors.

Abhijeet Ranjan *Department of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India.
Ankur Jindal *Department of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India.
Rakhi MaiwallDepartment of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India.
Chitranshu VashishthaDepartment of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India.
Rajan VijayaraghavanDepartment of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India.
Vinod AroraDepartment of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India.
Shiv K Sarin *Department of Hepatology, Institute of Liver and Biliary Sciences, D - 1, Vasant Kunj, New Delhi, 110070, India. shivsarin@gmail.com.ORCID http://orcid.org/0000-0002-0544-5610

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPropranolol, a non-selective beta-blocker, commonly used to prevent variceal bleed, but might precipitate circulatory dysfunction in severe ascites. Midodrine, an alpha-1 adrenergic agonist improves renal perfusion and systemic hemodynamics. Addition of midodrine might facilitate higher maximum tolerated dose (MTD) of propranolol, thereby less risk of variceal bleed in cirrhosis patients with severe ascites.

methods140 patients with cirrhosis and severe/refractory ascites were randomized- propranolol and midodrine (Gr.A,n = 70) or propranolol alone (Gr.B,n = 70). Primary outcome was incidence of bleed at 1 year. Secondary outcomes included ascites control, achievement of target heart rate (THR), HVPG response and adverse effects.

resultsBaseline characteristics were comparable between two groups. Cumulative incidence of bleed at 1 year was lower in Gr.A than B (8.5%vs.27.1%,p-0.043). The MTD of propranolol was higher in Gr.A (96.67 ± 36.6 mg vs. 76.52 ± 24.4 mg; p-0.01) and more patients achieved THR (84.2%vs.55.7%,p-0.034). Significantly higher proportion of patients in Gr.A had complete resolution of ascites [17.1%vs.11.4%,p-0.014), diuretic tolerance (80%vs.60%,p-0.047) at higher doses(p-0.02) and lesser need for paracentesis. Patients in Gr.A also had greater reduction in variceal grade (75.7%vs.55.7%;p-0.01), plasma renin activity (54.4% from baseline) (p = 0.02). Mean HVPG reduction was greater in Gr.A than B [4.38 ± 2.81 mmHg(23.5%) vs. 2.61 ± 2.87 mmHg(14.5%),p-0.045]. Complications like post-paracentesis circulatory dysfunction and spontaneous bacterial peritonitis on follow-up were higher in Gr.B than A (22.8%vs.51.4%,p = 0.013 and 10%vs.15.7%, p = 0.03, respectively).

conclusionAddition of midodrine facilitates effective use of propranolol in higher doses and greater HVPG reduction, thereby preventing first variceal bleed, reduced paracentesis requirements with fewer ascites- related complications in patients with cirrhosis with severe/refractory ascites.

Indexed as

AscitesGastrointestinal HemorrhageLiver CirrhosisMidodrinePropranololAdrenergic alpha-1 Receptor AgonistsAdrenergic beta-AntagonistsAdultAgedDrug Therapy, CombinationEsophageal and Gastric VaricesFemaleHumansMaleMiddle AgedTreatment OutcomeAdrenergic alpha-1 Receptor AgonistsAdrenergic beta-AntagonistsMidodrinePropranololBleedCirrhosisHVPGMidodrinePortal hypertensionVarices

Identifiers

PMID38727780

What OpenQuestion holds

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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.