Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock

NCT06742164 | Not Yet Recruiting

• 1 other identifier: ms 719/2023
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines. In this study, we evaluate the effect of enteral Ivabradine on outcome of septic patients regarding need for vasopressor therapy, mechanical ventilation, renal replacement therapy, length of ICU stay and in-hospital mortality.

Conditions

Heart Rhythm Disorder

Outcome Measures

Primary Outcomes (1)

• the percentage of patients with heart rate reduction of at least 10 beats/min

  after 72 hours of treatment

Secondary Outcomes (3)

• Mean heart rate

  72 hours of treatment

• Mean arterial blood pressure

  72 hours of treatment

• percentage of patients needed vasopressor

  72 hours of treatment

Study Arms (2)

Patients received Ivabradine

ACTIVE COMPARATOR

Drug: Ivabradine 5mg Tab

Patients didn't receive Ivabradine .

SHAM COMPARATOR

Drug: control

Interventions

Ivabradine 5mg Tab DRUG

Ivabradine (5 mg twice daily) orally or via nasogastric tube

Patients received Ivabradine

control DRUG

Patients didn't receive Ivabradine .

Patients didn't receive Ivabradine .

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with proven or suspected site of infection.
• Patients sepsis (acute organ dysfunction secondary to documented or suspected infection)
• Patients with septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure) for at least 6 hours and less than 24 hours.
• Patients with sinus rhythm with heart rate ≥ 95 bpm at time of randomization. Informed consent obtained in accordance with local regulations.

You may not qualify if:

• Cardiac arrhythmia, conduction disorder, sinus syndrome ("sick sinus syndrome"), atrial fibrillation and heart block.
• Cardiogenic shock or acute heart failure, without proven or suspected infection.
• Acute coronary syndrome.
• Refractory shock with systolic arterial pressure \<90 mm Hg despite the use of high doses of vasopressors.
• Co-treatment with drugs inducing bradycardia.
• Patients with pacemakers.
• Known pregnancy, breast-feeding, women with of childbearing potential will be tested for pregnancy and excluded if pregnant.
• Known allergy to Ivabradine
• Severe renal failure (creatinine clearance \<15 ml/min) or hepatic failure (prothrombin time \<20%)
• Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (\<7 g/dl)
• Enteral feeding impossible.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Ivabradine

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12