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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT04642768
Eligibility Criteria:
Inclusion Criteria:
* Ongoing treatment with inotropes and/or vasopressors because of cardiogenic shock as judged by the clinicians
* Patients are required at some point in time to have had \> 1 of the following: systolic blood pressure \< 90 mmHg; arterial blood lactate ≥ 2.5mmol/l; organ hypoperfusion (e.g. urinary output \< 0.5 ml/kg/hour or SvO2 \<55% with normal PaO2 and Hgb)
* LVEF \< 40%
* Age ≥ 18 years
Exclusion Criteria:
* Other primary causes of shock (hypovolemia, hemorrhage, severe infection or sepsis, pulmonary embolism or anaphylaxis),
* Shock due to mechanical complication to myocardial infarction (papillary muscle rupture, rupture of the ventricular septum or rupture of free wall)
* INTERMACS level 1 or 2 \[18\] with unstable or sliding hemodynamics on inotropes/vasopressors
* Use of or probable need for mechanic circulatory support (e.g. left ventricular assistant device, IMPELLA, extracorporeal membrane oxygenation)
* Recent post-cardiotomy cardiogenic shock (defined as thoracic surgery with the last 3 days)
* Inability to position a nasogastric tube
* Severe gastroparesis or abdominal distension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04642768
Study Brief:
Protocol Section:
NCT04642768