Health Condition 1: null- Septic shock
Conditions
Interventions
Intervention1: Group I: Enteral ivabradine 2.5 mg every 6 hours, titrated to heart rate.
Intervention2: Group I: Enteral ivabradine 2.5 mg every 6 hours, titrated to heart rate, in addition to standar
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients with septic shock, at least 24 hours after initiation of resuscitation, with HR more than 95 bpm, requiring noradrenaline support (1 - 25 mcg.min-1) to maintain MAP more than 65 mm Hg in spite of adequate volume resuscitation [corrected central venous pressure (CVP) more than 10 mm Hg and inferior vena cava diameter (IVCd) more than 1.5 cm].
Exclusion criteria
Exclusion criteria: 1. Patients with pre-existing cardiovascular disease (coronary artery disease, congestive heart failure, cardiac rhythm abnormalities and conduction defects, congenital heart disease, pace-maker in-situ). 2. Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate less than 15 ml.min-1. 3. Patients with severe liver dysfunction (MELD score more than 30). 4. Requirement of high dose noradrenaline (more than 25 mcg.min-1) or second vasopressor to maintain MAP more than 65 mm Hg. 5. Any contraindication to enteral drug administration (including patients of gastro-intestinal perforation, mechanical bowel obstruction and post-gut resection-anastomosis). 6. Pregnancy, lactation 7. Patients less than 18 years and more than 75 years of age 8. Patients with active bleeding 9. Post-cardiac arrest patients 10. Hb less than 7 g/dL 11. BMI more than 35 12. Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole-type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin) and HIV protease inhibitors (nelfinavir, ritonavir).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is difference in HR between the two groups during the first 96 hour after recruitment.Timepoint: 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include 96 hour difference in MAP, NA requirement, CI, SVI, LVEF, arterial lactate, PaO2-FiO2 ratio, proBNP, Troponin I (Trop I), creatinine, bilirubin and APACHE II score; difference in incidence of severe bradycardia, heart block, atrial fibrillation (AF) and MACE; requirement of RRT, duration of vasopressor requirement, mechanical ventilation and ICU stay; and 30-day ICU mortality.Timepoint: 96 hours, 30-day | — |
Countries
India
Contacts
Public ContactPriyankar Kumar Datta
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed