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

NCT ID: NCT06742164

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-06-30

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.

Detailed Description

All patients will be subjected to:

1. Thorough history taking:

• Demographic data: age, sex and residence.
• Clinical presentation (fever, hypotension , tachycardia , tachypnea and anuria) .
• Family history of immunodeficiency disease
• History of recurrent

2. Clinical examination:

• Vital signs: heart rate (HR) , blood pressure (BP), and temperature.
• Abdominal examination .
• Detect septic focus .
• Urine out put .
• Follow up until discharge from ICU.

3. Laboratory investigations:

All patient will be screened with :

• Kidney function test .
• Liver function test.
• Total leukocyticcount was assessed immediately after admission to ICU and then every other day
• C-reactive protien was assessed immediately after admission to ICU and then every other day
• Broad-spectrum antibiotic and then according to cultures and sensitivity.
• Radiological investigation .
• Abdominal ultrasound.
• ECG.
• Echocardiography.

Study tools and procedures:

Epidemiological, demographic, clinical, laboratory, treatment, and outcome data will be obtained from medical records using a standardized data collection form.

Data will be obtained by Randomized controlled clinical trial (RCT) of medical records after, the study methodology reviewed and approved by the Research Review Board of Alhelal hospital (Intensive care unit), Faculty of medicine, Ain Shams University hospitals (Intensive care unit) .

The point of enrolment after initial haemodynamic stabilisation was taken as time 0. The following data sets were recorded at the specified time intervals.

An arterial line and central venous catheter were inserted in all patients for invasive blood pressure and central venous pressure monitoring. The point of enrolment after initial haemodynamic stabilisation was taken as time 0.

If the heart rate was less than 70 beats /min. the dose was omitted. The initial mangement of patients with sepsis and septic shock is summarised on three pillars of therapy.

Stabilization of haemodynamics with target mean arterial blood pressure at 65 mmHg for most patients, begain to rapidly administer 30ml/kg balanced crystalloid within 3 hours for hypotension or lactate ≥ 4mmol/L , Apply vasopressor if hypotensive during or after fluid resuscitation (The vasopressor of choice in septic shock is noradrenaline) , Hydrocortisone 100-200 mg/day is added In patients with refractory hypotension Obtain blood cultures before administration antibiotics. Control source of sepsis. Patients in group (A)were administered 5 mg ivabradine ( orally or crushed and injected through the enteral feeding tube every 12 hours.Heart rate was assessed prior to each dose.

Group (B): Patients didn't receive Ivabradine .

Conditions

Heart Rhythm Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Patients received Ivabradine

Group Type: ACTIVE_COMPARATOR

Ivabradine 5mg Tab

Intervention Type: DRUG

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

Patients didn't receive Ivabradine .

Group Type: SHAM_COMPARATOR

control

Intervention Type: DRUG

Patients didn't receive Ivabradine .

Interventions

Ivabradine 5mg Tab

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

Intervention Type: DRUG

control

Patients didn't receive Ivabradine .

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

RAMY AHMED

Assistant Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ms 719/2023

Identifier Type: -

Identifier Source: org_study_id