Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 5, 2025
Open Peer Review Period: Dec 8, 2025 - Feb 2, 2026
Date Accepted: Apr 20, 2026
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The ALIVe Study: A Study Protocol for the Compilation of Literature, Subsequent Expert Consensus, and a Clinical Pharmacist-Led Validation Study on Dose Recommendations for Drugs in Patients with Liver Cirrhosis
ABSTRACT
Background:
Liver cirrhosis leads to an impaired liver function with reduced metabolisation capacity which affects the pharmacokinetics of several drugs requiring dose adjustments. Although limited literature provides guidance on appropriate administration of drugs in cirrhosis, no guidelines currently existfor dose selection or adjustment.
Objective:
The objective of this study is to provide guidance on the selection, dosing and appropriate use of drugs in patients with liver cirrhosis and to evaluate the clinical application of these recommendations.
Methods:
Three steps are planned to establish dose recommendations for patients with liver cirrhosis: (1) A systematic literature search will be conducted to identify specific recommendations for drug selection and dosing in cirrhosis and assessed for reporting quality and evidence level. Subsequently, the resulting recommendations will be undergo an internal pre-assessment procedure for relevance of the covered drugs with regard to availability, the clinical impact of adverse drug reactions, the frequency of use and the expected benefit of dose adjustment. (2) A modified Delphi procedure will be conducted to (a) analyze the clinical handling of the identified drugs by experts in clinical practice in a first round and (b) harmonize differing dose recommendations in a second round. (3) Finally, the adopted dose recommendations will be implemented in a clinical study involving patients with liver cirrhosis to analyze their impact on the patients´ safety.
Results:
The study has been registered in the German Registry of Clinical Trials (DRKS00033779), and the planned clinical validation phase is currently underway.
Conclusions:
This protocol outlines a structured approach combining a systematic literature review of specific dose recommendations in patients with cirrhosis integrating a quality assessment to ensure the inclusion of only high-quality evidence, expert opinions by a Delphi consensus aligning differing recommendations and a clinical validation to support safer drug therapy in patients with liver cirrhosis. Clinical Trial: This study was registered in the German Registry of Clinical Trials (DRKS) on 2024-12-27 with code number DRKS00033779 (https://www.drks.de/search/de/trial/DRKS00033779 ).
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