Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT02120404
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02120404
Study Brief:
Protocol Section:
NCT02120404