Effectiveness of enteral ivabradine for heart rate control in septic shock – A randomized controlled trial.

All India Institute of Medical Sciences New Delhi0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年7月22日

研究概览

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•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].

•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).

发起方

All India Institute of Medical Sciences New Delhi