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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivabradine 5mg Tab

    Drug

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

  • control

    Drug

    Patients didn't receive Ivabradine .

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Patients received IvabradineActive comparator 1 intervention
Group B: Patients didn't receive Ivabradine .Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
after 72 hours of treatment

Secondary outcomes

1

Mean heart rate

Time frame
72 hours of treatment
2

Mean arterial blood pressure

Time frame
72 hours of treatment
3

percentage of patients needed vasopressor

Time frame
72 hours of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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