Recruitment

Recruitment Status
Active, not recruiting

Inclusion Criteria

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;
Treatment with noradrenaline for less than 48 hours.
Hemodynamic stability of patient during 1 hour without change in norepinephrine dosage;
...
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;
Treatment with noradrenaline for less than 48 hours.
Hemodynamic stability of patient during 1 hour without change in norepinephrine dosage;
Patient aged ≥ 18 years;
Patient with septic shock;
Patient with arterial catheter, central venous catheter with PVC and PiCCO;

Exclusion Criteria

Need of noradrenaline > 3 mg/h;
Personal history of severe chronic obstructive pulmonary disease;
Therapeutic futility;
...
Need of noradrenaline > 3 mg/h;
Personal history of severe chronic obstructive pulmonary disease;
Therapeutic futility;
Concomitant treatment with bepridil, diltiazem, verapamil, amiodarone, propafenone, Class Ia antiarrythmics (hydroquinidine, disopyramide) or baclofen;
Patient with pacemaker;
Personal history of pulmonary hypertension;
Patient under the care of a guardian;
Peripheral arterial disease;
Chronic treatment with a beta blocker;
Pregnancy woman;
Mean arterial pressure < 65 mm Hg;
Personal history of sinoatrial block without pacemaker;
Personal history of second degree or third degree atrioventricular block without pacemaker;
Patient < 18 years;
Personal history of severe asthma;
Lack of medical insurance.
Hypersensitivity to esmolol;
Breastfeeding woman;
Chronic heart failure with ejection fraction < 40%;
Pheochromocytoma without treatment;
Treatment with dobutamine;
Severe atrioventricular nodal bradycardia (heart rate < 70 bpm);
Prinzmetal angina;

Summary

Conditions
Septic Shock
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

During septic shock, the consequences of treatment by a β1-blocker on inflammation and cardiovascular variability are unknown. The use of esmolol should have positive effects on inflammation and hemodynamic tolerance. These effects are probably dose-dependent. The study will enroll adult patients ho...

During septic shock, the consequences of treatment by a β1-blocker on inflammation and cardiovascular variability are unknown. The use of esmolol should have positive effects on inflammation and hemodynamic tolerance. These effects are probably dose-dependent. The study will enroll adult patients hospitalized in ICU, for severe septic shock requiring treatment by a vasopressor. A total of 45 patients will be included. Among these 45 patients, 15 patients will be randomized in the control group. 30 patients will be randomized to Esmolol with the objective to decrease heart rate by 10% (Group G10, n=15) or 20% (Group G20, n=15). Esmolol will be administered for 24 hours. This multicenter study will be performed in 3 investigation sites. The following parameters will be evaluated at different moments during the 28 days follow up of each patient, mainly: Origin of sepsis, SOFA score. Hemodynamic parameters will be continuously recorded for the 24 hours of experimental period. Cardiovascular variability (arterial pressure and heart rate) will be recorded for 24 hours. 3 echocardiograms at H0, H12 and H24 will be performed. Biological parameters will be sampled at H0, H6, H12 and H24: They include standard biological parameters (Urea, Creatinin, Bilirubin,……) and specific parameters (catecholamines, vasopressin, insulin, cortisol, proinflammatory cytokines and anti-inflammatory cytokines. Dosages will be performed only at H0, H12 and H24 in order to study: The expression of adrenergic receptors and their genetic polymorphisms on circulating immune cells. The Th1/Th2 balance in immune cells. Each patient will be followed-up for 28 days. The variation of MAP and of cardiac output induced by esmolol should not exceed 15% of baseline values. If the variation is more important esmolol administration will be stopped and the hemodynamical tolerance will be defined as poor.

Inclusion Criteria

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;
Treatment with noradrenaline for less than 48 hours.
Hemodynamic stability of patient during 1 hour without change in norepinephrine dosage;
...
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;
Treatment with noradrenaline for less than 48 hours.
Hemodynamic stability of patient during 1 hour without change in norepinephrine dosage;
Patient aged ≥ 18 years;
Patient with septic shock;
Patient with arterial catheter, central venous catheter with PVC and PiCCO;

Exclusion Criteria

Need of noradrenaline > 3 mg/h;
Personal history of severe chronic obstructive pulmonary disease;
Therapeutic futility;
...
Need of noradrenaline > 3 mg/h;
Personal history of severe chronic obstructive pulmonary disease;
Therapeutic futility;
Concomitant treatment with bepridil, diltiazem, verapamil, amiodarone, propafenone, Class Ia antiarrythmics (hydroquinidine, disopyramide) or baclofen;
Patient with pacemaker;
Personal history of pulmonary hypertension;
Patient under the care of a guardian;
Peripheral arterial disease;
Chronic treatment with a beta blocker;
Pregnancy woman;
Mean arterial pressure < 65 mm Hg;
Personal history of sinoatrial block without pacemaker;
Personal history of second degree or third degree atrioventricular block without pacemaker;
Patient < 18 years;
Personal history of severe asthma;
Lack of medical insurance.
Hypersensitivity to esmolol;
Breastfeeding woman;
Chronic heart failure with ejection fraction < 40%;
Pheochromocytoma without treatment;
Treatment with dobutamine;
Severe atrioventricular nodal bradycardia (heart rate < 70 bpm);
Prinzmetal angina;

Tracking Information

NCT #
NCT02120404
Collaborators
Baxter Healthcare Corporation
Investigators
  • Principal Investigator: Djillali ANNANE, MD, PhD ICU, Hôpital Raymond Poincaré, 92380 Garches, France
  • Djillali ANNANE, MD, PhD ICU, Hôpital Raymond Poincaré, 92380 Garches, France
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