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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30223 - Anaesthesiology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

Trials

ISSN

1745-6215

e-ISSN

—

Svazek periodika

19

Číslo periodika v rámci svazku

November

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

—

Kód UT WoS článku

000451332900003

EID výsledku v databázi Scopus

2-s2.0-85056694904