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Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial
- Source :
- Trials, Vol 19, Iss 1, Pp 1-8 (2018), Trials
- Publication Year :
- 2018
- Publisher :
- BMC, 2018.
-
Abstract
- Background In patients with septic shock, the presence of an elevated heart rate (HR) after fluid resuscitation marks a subgroup of patients with a particularly poor prognosis. Several studies have shown that HR control in this population is safe and can potentially improve outcomes. However, all were conducted in a single-center setting. The aim of this multicenter study is to demonstrate that administration of the highly beta1-selective and ultrashort-acting beta blocker landiolol in patients with septic shock and persistent tachycardia (HR ≥ 95 beats per minute [bpm]) is effective in reducing and maintaining HR without increasing vasopressor requirements. Methods A phase IV, multicenter, prospective, randomized, open-label, controlled study is being conducted. The study will enroll a total of 200 patients with septic shock as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria and tachycardia (HR ≥ 95 bpm) despite a hemodynamic optimization period of 24–36 h. Patients are randomized (1:1) to receive either standard treatment (according to the Surviving Sepsis Campaign Guidelines 2016) and continuous landiolol infusion to reach a target HR of 80–94 bpm or standard treatment alone. The primary endpoint is HR response (HR 80–94 bpm), the maintenance thereof, and the absence of increased vasopressor requirements during the first 24 h after initiating treatment. Discussion Despite recent studies, the role of beta blockers in the treatment of patients with septic shock remains unclear. This study will investigate whether HR control using landiolol is safe, feasible, and effective, and further enhance the understanding of beta blockade in patients with septic shock. Trial registration EU Clinical Trials Register; EudraCT, 2017-002138-22. Registered on 8 August 2017. Electronic supplementary material The online version of this article (10.1186/s13063-018-3024-6) contains supplementary material, which is available to authorized users.
- Subjects :
- Time Factors
Surviving Sepsis Campaign
Medicine (miscellaneous)
Blood Pressure
Clinical Trials, Phase IV as Topic
030204 cardiovascular system & hematology
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Heart Rate
law
Septic shock
Tachycardia
Multicenter Studies as Topic
Urea
Vasoconstrictor Agents
Medicine
Pharmacology (medical)
Prospective Studies
Randomized Controlled Trials as Topic
education.field_of_study
lcsh:R5-920
Standard treatment
Shock, Septic
Intensive care unit
Europe
Intensive Care Units
Treatment Outcome
Anesthesia
lcsh:Medicine (General)
Anti-Arrhythmia Agents
medicine.drug
Morpholines
Adrenergic beta-Antagonists
Population
Sepsis
03 medical and health sciences
Humans
Beta-blocker
education
business.industry
030208 emergency & critical care medicine
Landiolol
medicine.disease
business
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 19
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....f0a0e36f7a8d1c52e45d570d3f6733e3