Effect of heart rate control with ivabradine on hemodynamic in patients with sepsis: study protocol for a prospective, multicenter, randomized controlled trial.
Humans
Ivabradine
/ therapeutic use
Heart Rate
/ drug effects
Prospective Studies
Sepsis
/ drug therapy
Hemodynamics
/ drug effects
Randomized Controlled Trials as Topic
Treatment Outcome
Multicenter Studies as Topic
Middle Aged
Male
Adult
Female
Aged
Cardiovascular Agents
/ therapeutic use
Time Factors
Hemodynamic
Ivabradine
Randomized controlled trial
Sepsis
Tachycardia
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Oct 2024
23 Oct 2024
Historique:
received:
02
02
2024
accepted:
14
10
2024
medline:
24
10
2024
pubmed:
24
10
2024
entrez:
24
10
2024
Statut:
epublish
Résumé
Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of hypovolemia and hypotension have been corrected. Recently, relevant studies have shown that sustained tachycardia in sepsis was related to high mortality, and appropriate control of heart rate (HR) could improve prognosis. Ivabradine reduces HR directly without a negative inotropic effect through inhibition of the I This is a prospective, multicenter, randomized, open label study designed to investigate the effect of heart rate control with ivabradine on hemodynamic in patients with sepsis. Our study will enroll 172 patients with sepsis as defined by The Third International Consensus Definitions for Sepsis and Septic Shock criteria with sinus rate of 95 bpm or higher despite a hemodynamic optimization. Patients will be randomly assigned to standard treatment group (GS) or ivabradine group (GI, standard treatment for sepsis plus enteral ivabradine). Patients in GI will receive ivabradine to maintain HR between 70 and 94 bpm. The primary outcome is the difference of a reduction in HR below 95 bpm and the effect of ivabradine on hemodynamics between GI and GS group within the first 96 h after randomization. The secondary outcomes include organ function measures, the difference in SOFA score, incidence of adverse events, need for organ support, length of ICU stay, and 28-day overall mortality. There are limited studies on ivabradine to control heart rate in patients with sepsis. Our study aims to evaluate whether direct sinus node inhibition can improve hemodynamics, as well as its impact on organ function and prognosis in patients with sepsis, so as to provide evidence for the safe usage in clinical practice. ClinicalTrials.gov NCT05882708. Registered on May 11, 2023, https://clinicaltrials.gov/ct2/show/NCT05882708 .
Identifiants
pubmed: 39443954
doi: 10.1186/s13063-024-08560-5
pii: 10.1186/s13063-024-08560-5
doi:
Substances chimiques
Ivabradine
3H48L0LPZQ
Cardiovascular Agents
0
Banques de données
ClinicalTrials.gov
['NCT05882708']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
710Informations de copyright
© 2024. The Author(s).
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