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Invasive Hemodynamic Characterization of the Portal-hypertensive Syndrome in Cirrhotic Rats
Published on: August 1, 2018
Review article: definition and diagnosis in portal hypertension--continued problems with the Baveno consensus?
1Gastroenterology and Gastrointestinal Endoscopy Service, Department of Internal Medicine, University of Milan, IRCCS Ospedale Policlinico, Italy. gastro@policlinico.mi.it
Insights
The Baveno workshops established consensus definitions and guidelines for portal hypertension and variceal bleeding clinical trials. A study found tachycardia, a bleeding control criterion, was misleading in 15% of patients.
Area of Science:
- Gastroenterology
- Clinical Trial Methodology
- Hepatology
Background:
- Portal hypertension and variceal bleeding necessitate standardized definitions and guidelines for clinical research.
- Previous Baveno workshops aimed to establish consensus on key events and trial conduct.
Purpose of the Study:
- To develop consensus definitions for portal hypertension and variceal bleeding events.
- To create guidelines for conducting and reporting clinical trials in this field.
- To evaluate the applicability of existing Baveno definitions.
Main Methods:
- Consensus development through expert workshops.
- Formulation of definitions for bleeding, rebleeding, and prophylaxis.
- Evaluation of Baveno definitions in a clinical study setting.
- Testing criteria such as tachycardia for failure to control bleeding.
Main Results:
- Consensus definitions for active bleeding, bleeding control failure, rebleeding, and prophylaxis were established.
- Guidelines were produced for diagnostic endoscopy, fluid resuscitation, infection prevention, and treatment.
- The study evaluating Baveno definitions identified tachycardia as a misleading criterion in 15% of patients.
Conclusions:
- The Baveno definitions and guidelines provide a framework for portal hypertension and variceal bleeding research.
- Ongoing adaptation based on practical application is intended.
- Refinement of diagnostic criteria, like tachycardia, is necessary for improved clinical trial accuracy.
Abstract:
The goals of the Baveno workshops were to develop consensus definitions of key events related to portal hypertension and variceal bleeding, and to produce guidelines to facilitate the conduct and reporting of clinical trials. The consensus definitions concern the diagnosis of active bleeding, failure to control bleeding, the criteria to distinguish continuing bleeding from rebleeding, and the means of assessing failure to prevent rebleeding. The guidelines concern the timing of diagnostic endoscopy, the policy for blood volume restitution, the measures to prevent infection and encephalopathy, and the treatment options for acute bleeding, as well as primary and secondary prophylaxis. The intention of the experts who developed the guidelines was that, as feedback from their practical application develops, they should be adapted to better fit the practical needs. The applicability of the Baveno definitions has been evaluated in a study where the definitions of clinically significant bleeding, failure to control bleeding, the time frame for the acute bleeding episode and the definition of rebleeding were tested. The main criticism raised in this study was that tachycardia, one of the criteria that define failure to control bleeding, was misleading in 15% of patients who had the symptom but were not bleeding.
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