Trial of ivabradine for controlling high heart rate control in septic shock.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Septic shock

• Registration Number: CTRI/2017/09/009849
• Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is difference in HR between the two groups during the first 96 hour after recruitment.Timepoint: 96 hours

Secondary Outcome Measures

Name	Time	Method
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