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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.

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.

SUBMITTER: Unger M

PROVIDER: S-EPMC6245811 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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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.

Unger Martin M Morelli Andrea A Singer Mervyn M Radermacher Peter P Rehberg Sebastian S Trimmel Helmut H Joannidis Michael M Heinz Gottfried G Cerny Vladimír V Dostál Pavel P Siebers Christian C Guarracino Fabio F Pratesi Francesca F Biancofiore Gianni G Girardis Massimo M Kadlecova Pavla P Bouvet Olivier O Zörer Michael M Grohmann-Izay Barbara B Krejcy Kurt K Klade Christoph C Krumpl Günther G

Trials 20181119 1

<h4>Background</h4>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 p ...[more]

PMID: 30454042

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Project description:Background: The impact of intensive care unit (ICU) admission during life-threatening critical illness on survival of patients with advanced cancer remains unknown. Methods: We identified incident stage IV cancer patients from Taiwan Cancer Registry during 2009-2013 and ascertained the first episode of septic shock after cancer diagnosis. Patient was classified as ICU admission and no ICU admission during the index hospitalization. Primary outcome of interest was overall survival. Propensity score (PS) and proportional hazards regression were used to control potential confounders. Results: A total of 11,825 stage IV cancer patients with septic shock were identified. Among them, 6,089 (51.5%) patients were admitted to ICU during the index hospitalization and 3,626 (30.7%) patients survived the index hospitalization. A 1:1 propensity score (PS)-matched cohort of 7,186 patients were created for patients with/without ICU admission among the total study population. Both the PS-stratified analysis among the overall population (pooled hazard ratio [HR]: 0.78, 95% confidence interval [CI]: 0.74-0.81) and analysis among the PS-matched population (HR: 0.76, 95% CI: 0.72-0.79) showed association between ICU admission and better overall survival. ICU admission was also associated with a lower risk of in-hospital mortality in both PS-stratified analysis (pooled odds ratio [OR]: 0.69, 95% CI: 0.63-0.75) and PS-matched analysis (OR: 0.61, 95% CI: 0.55-0.68). In PS-stratified analysis for long-term survival after discharge among hospital survivors, ICU admission was associated with improved long-term survival after discharge (pooled HR: 0.73, 95% CI: 0.68-0.80). Also ICU admission was associated with better long-term survival after discharge (HR: 0.77, 95% CI: 0.70-0.85) in PS-matched analysis. Conclusions: Though ICU admission with aggressive treatment may be associated with improved survival, the majority (70%) of stage IV cancer patients with septic shock were unable to survive until hospital discharge.

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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.

Publications

Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial.

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