Related Experiment Video
Updated: Jun 11, 2026
12:24
A Three-Dimensional Spheroid Model to Investigate the Tumor-Stromal Interaction in Hepatocellular Carcinoma
Published on: September 30, 2021
Dose Recommendations for Drugs in Patients With Liver Cirrhosis (The ALIVe Study): Protocol for a Multiphase
Katharina Karsten Dafonte1, Philipp Lutz2, Christian Jansen2
1Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Venusberg-Campus 1, Bonn, 53127, Germany, 49 22828714036.
JMIR Research Protocols
|June 10, 2026
Summary
This study establishes evidence-based drug dosing guidelines for liver cirrhosis patients by combining literature reviews, expert consensus, and clinical validation. These recommendations aim to improve drug safety and efficacy in individuals with impaired liver function.
Area of Science:
- Pharmacology
- Hepatology
- Clinical Pharmacy
Background:
- Liver cirrhosis impairs drug metabolism and pharmacokinetics, necessitating dose adjustments.
- Current literature lacks specific guidelines for drug selection and dosing in cirrhosis patients.
- Altered liver function in cirrhosis impacts drug efficacy and safety profiles.
Purpose of the Study:
- To develop evidence-based recommendations for drug selection, dosing, and appropriate use in liver cirrhosis.
- To evaluate the clinical applicability and impact of these drug dosing guidelines.
- To enhance drug therapy management for patients with liver cirrhosis.
Main Methods:
- Systematic literature review to identify existing drug dosing recommendations for cirrhosis, with quality and evidence assessment.
- Internal preassessment of identified recommendations for clinical relevance, drug availability, and impact of adverse events.
- Modified Delphi procedure involving expert consensus to refine and harmonize dose recommendations.
- Clinical validation of adopted recommendations in a study with liver cirrhosis patients to assess safety.
Main Results:
- The clinical validation phase, initiated in January 2025, is ongoing with 121 patients enrolled as of May 2026.
- Detailed findings from the literature review, Delphi consensus, and clinical validation will be published subsequently.
- Final study results and data analysis are expected by August 2026.
Conclusions:
- This protocol outlines a comprehensive strategy for developing drug dosing guidelines in liver cirrhosis.
- The approach integrates high-quality evidence, expert consensus, and clinical validation for improved patient safety.
- The study aims to provide crucial guidance for safer and more effective drug therapy in cirrhosis management.
Related Concept Videos
01:26Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow
Chronic liver disease significantly impacts drug metabolism due to alterations in hepatic blood flow and enzyme accessibility. This disruption affects the body's pharmacokinetics—the movement and processing of drugs within the system. Key enzymes crucial for metabolizing medications become less accessible, changing how drugs are processed and utilized. Furthermore, liver disease influences the synthesis of plasma proteins, such as albumin and globulins, which play critical roles in drug binding...
01:22Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess the...
01:25Drug Dosing in Renal Diseases: Dose Adjustments Based on Drug Clearance and Elimination Rate Constant
In patients with renal disease, dosage adjustments are necessary to maintain therapeutic plasma drug concentrations and prevent toxicity or subtherapeutic exposure. Renal impairment alters drug pharmacokinetics, especially in conditions like uremia, where changes such as prolonged elimination half-life and altered apparent volume of distribution can significantly affect drug disposition. These changes require careful modification of the dosing regimen to achieve the desired clinical...
01:25Determination of Multiple Dosing Parameters: Loading and Maintenance Doses
A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...
01:08Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment
Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
01:11Renal Failure: Dose Adjustments
In patients with renal impairment, drugs undergo significant changes in their pharmacokinetics, which require dosage adjustments to ensure safe and effective therapy.
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...
Reduced renal clearance and elimination rate are common outcomes of renal impairment. These alterations lead to a prolonged elimination half-life and an altered apparent volume of distribution for drugs. As a result, dosage adjustments are typically necessary to maintain optimal drug levels in the body.
However, dosage adjustments...