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Landiolol in patients with septic shock resident in a intensive care unit (LANDISEP): study protocol for a randomized controlled trial

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F18%3A10383073" target="_blank" >RIV/00179906:_____/18:10383073 - isvavai.cz</a>

  • Result on the web

    <a href="https://doi.org/10.1186/s13063-018-3024-6" target="_blank" >https://doi.org/10.1186/s13063-018-3024-6</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1186/s13063-018-3024-6" target="_blank" >10.1186/s13063-018-3024-6</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Landiolol in patients with septic shock resident in a intensive care unit (LANDISEP): study protocol for a randomized controlled trial

  • Original language description

    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 GREATER-THAN OR EQUAL TO 95 beats per minute [bpm]) is effective in reducing and maintaining HR without increasing vasopressor requirements. 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 GREATER-THAN OR EQUAL TO 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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30223 - Anaesthesiology

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2018

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Trials

  • ISSN

    1745-6215

  • e-ISSN

  • Volume of the periodical

    19

  • Issue of the periodical within the volume

    November

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    8

  • Pages from-to

  • UT code for WoS article

    000451332900003

  • EID of the result in the Scopus database

    2-s2.0-85056694904