Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is :

• to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart rate of 10% or 20%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Baxter Healthcare Corporation
• Treatments: Anti-Inflammatory Agents; Esmolol

Criteria

Inclusion Criteria:

• Patient aged ≥ 18 years;

• Patient with septic shock;

• Patient with arterial catheter, central venous catheter with PVC and PiCCO;

• Consent signed by patient. In the absence of a consent signed by patient himself, a consent by a family member will be sought. As soon as possible, the patient will be informed and asked to sign a consent for continuing of study;

• Hemodynamic stability of patient during 1 hour without change in norepinephrine dosage;

• Treatment with noradrenaline for less than 48 hours.

Exclusion Criteria:

• Need of noradrenaline > 3 mg/h;

• Treatment with dobutamine;

• Personal history of severe asthma;

• Personal history of severe chronic obstructive pulmonary disease;

• Personal history of pulmonary hypertension;

• Personal history of second degree or third degree atrioventricular block without pacemaker;

• Personal history of sinoatrial block without pacemaker;

• Chronic heart failure with ejection fraction < 40%;

• Severe atrioventricular nodal bradycardia (heart rate < 70 bpm);

• Mean arterial pressure < 65 mm Hg;

• Hypersensitivity to esmolol;

• Prinzmetal angina;

• Pheochromocytoma without treatment;

• Pregnancy woman;

• Breastfeeding woman;

• Peripheral arterial disease;

• Patient with pacemaker;

• Chronic treatment with a beta blocker;

• Concomitant treatment with bepridil, diltiazem, verapamil, amiodarone, propafenone, Class Ia antiarrythmics (hydroquinidine, disopyramide) or baclofen;

• Patient < 18 years;

• Patient under the care of a guardian;

• Therapeutic futility;

• Lack of medical insurance.