Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the T… (NCT02120404) | Clinical Trial Compass
UnknownPhase 2
Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock
France45 participantsStarted 2015-04
Plain-language 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%.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 u…
What they're measuring
1
Comparison of hemodynamic parameters between 3 groups