Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: IVABRADINE: Ivabradine tablet will be administered orally in patients who are able to swallow, or crushed and administered through Ryleâ??s tube, every 12 hours. The dose of ivabradine
Sponsors
Dept of Anaesthesiology, Pain Medicine and Critical Care
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with septic shock (noradrenaline requirement 0.1 â?? 0.5 mcg/kg/min, with or without vasopressin) and sinus tachycardia with heart rate more than 110 bpm, after at least 12 hours of ICU admission and stabilization.
Exclusion criteria
Exclusion criteria: 1 Cardiac arrhythmias 2 LVEF less than 30% 3 Known structural heart disease 4 QT prolongation (QTc more than 460ms) 5 Ongoing active blood loss 6 Anemia (Hb less than 7 g%) 7 High grade fever (more than 104 deg F) 8 Serum lactate more than 10 mmol/L 9 SpO2 less than 92% 10 Need for third vasoactive inotropic agent (other than noradrenaline and vasopressin) 11 Pregnancy & lactation 12 Severe chronic liver disease (Child-Pugh C), acute or acute-on-chronic liver failure 13 End-stage renal disease (CKD V) 14 Absolute contradiction to enteral drug administration 15 High dose noradrenaline requirement (more than 1 mcg/kg/min) 16 Post-cardiac arrest patient 17 Patients with intracerebral SOL or raised ICP 18 Allergy to any of the intervention drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of time points at which the heart rate target (less than 90 bpm) was achieved and Mean Vasoactive-Inotropic Score.Timepoint: Both primary outcomes will be recorded at baseline and then at every 6 hours interval from enrolment, up to 96 hours. (At 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 hours from enrolment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Left ventricular ejection fraction (LVEF) Timepoint: Recorded daily over 96 hours ;Cardiac Troponin I and NT-ProBNP levelsTimepoint: At baseline and 96 hours;Mean cardiac output over 96 hours, using LiDCO systemTimepoint: Recorded every 6 hours for 96 hours;Mean systemic vascular resistance over 96 hoursTimepoint: Recorded every 6 hours for 96 hours;Mean lactate levels over 96 hoursTimepoint: Assessed daily;Mean capillary refill time over 96 hoursTimepoint: Assessed thrice daily;Mean SOFA score over 96 hoursTimepoint: Assessed daily;Vasopressor-free days at day 30Timepoint: At Day 30;Organ support-free days (vasopressors, RRT, ventilator) at day 30Timepoint: At Day 30;ICU-free days at day 30Timepoint: At Day 30;ICU mortality at day 7 and day 30Timepoint: At Day 7 and Day 30;Incidence of major adverse events (symptomatic bradycardia, arrhythmias)Timepoint: Daily;Cost of treatmentTimepoint: At 96 hours | — |
Countries
India
Contacts
Public ContactDR PRIYANKAR KUMAR DATTA
AIIMS NEW DELHI
Outcome results
None listed