Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Ivabradine plus standard therapy for septic shock: Patients in the intervention group were administered 5 mg of Ivabradine, either orally or crushed and delivered via a feeding tube (pr
Sponsors
Chackappen D Aymanom
Eligibility
Inclusion criteria
Inclusion criteria: 1. Septic shock diagnosed within 24 hours (Patients with heart rate more than 100 beats per minute and requiring noradrenaline support of 0.02-0.4 mcg/kg/min to maintain mean arterial pressure (MAP) above 65 mmHg despite adequate volume resuscitation) 2. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients less than 18 years or more than 80 years of age. 2. Pre-existing cardiovascular disease (coronary artery disease, congestive heart failure, cardiac rhythm abnormalities, conduction defects, congenital heart disease, or pacemaker in situ, post-cardiac arrest patients). 3. Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate less than 15 mL/min. 4. Severe hepatic insufficiency (Model for End-Stage Liver Disease (MELD) score more than 30, serum bilirubin more than 2.5 times upper limit of normal (ULN), or serum transaminases more than five times ULN). 5. Pregnant or lactating patients. 6. Patients with hemoglobin less than 7 g/dL. 7. Patients with any contraindication to enteral drug administration (including patients with gastrointestinal perforation, mechanical bowel obstruction, or bowel ischemia). 8. Use of potent cytochrome P450 3A4 inhibitors such as azole-type antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin), or HIV protease inhibitors (nelfinavir, ritonavir). 9. Patients with hyperthyroidism. 10. Patients with a baseline heart rate less than 70 beats per minute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in heart rate between the two groups during the first 96 hours after enrolment Timepoint: Time points for assessing the heart rate are: 1. At enrolment 2. At 24 hours 3. At 48 hours 4. At 96 hours These measurements will be recorded over the course of the 18-month trial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of IVABRADINE on 14 day MortalityTimepoint: 14 days;Effect of IVABRADINE on 24 hour urine outputTimepoint: 24 hours;Effect of IVABRADINE on ejection fractionTimepoint: Time points for assessing are: 1. At enrolment 2. At 24 hours 3. At 48 hours 4. At 96 hours;Effect of Ivabradine on Mean arterial pressureTimepoint: Time points for assessing 1.At enrolment 2. At 24 hours 3. At 48 hours 4. At 96 hours;Effect of IVABRADINE on severity of sepsis assessed by following parameters Serum lactate levels, SOFA score,PaO2/FiO2 , SCvO2,GCSTimepoint: Time points for assessing are: 1. At enrolment 2. At 24 hours 3. At 48 hours 4. At 96 hours;Effect of IVABRADINE on vasopressor ( Noradrenaline dose in mcg/kg/min) useTimepoint: Time points for assessing are: 1. At enrolment 2. At 24 hours 3. At 48 hours 4. At 96 hours;Length of ICU STAYTimepoint: Total length of ICU stay in days | — |
Countries
India
Contacts
Public ContactChackappen D Aymanom
AIIMS RISHIKESH
Outcome results
None listed