Clinical trial
Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock
Name
P120912
Description
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%.
Trial arms
Trial start
2015-04-01
Estimated PCD
2023-10-01
Trial end
2023-10-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Esmolol administration
Esmolol will be administered during 24 hours, beginning with a titration period to determine the minimal dose allowing to achieve the randomized heart rate reduction of 10% or 20%, as defined by randomization.
Titration will be performed in sequences of increasing doses, beginning with 5 μg/kg/min as initial dose, and increasing by 5 μg/kg/min each 30 minutes until the target heart rate reduction is obtained. The maximum dose is 200 μg/kg/min.
The titrated dose will be maintained for a total duration of 24 hours.
Arms:
Group 10 (G10), Group 20 (G20)
Other names:
BREVIBLOC 10 mg/ml
Size
45
Primary endpoint
Comparison of hemodynamic parameters between 3 groups
24 hours
Immunomodulatory effect
24 hours
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2023-08-31
1 organization
1 product
1 indication
Organization
Assistance Publique - Hôpitaux de ParisProduct
EsmololIndication
Septic shock