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:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01374867
Eligibility Criteria:
Inclusion Criteria:
* Cardiogenic shock with hypotension or severe low output syndrome within 6 hours from identification of it Clinical findings of cardiogenic shock: acute heart failure and
* Hypotension (systolic blood pressure under 90mmHg despite adequate fluid challenge) over 30 min time
* OR a need for vasopressor treatment (eg dopamine or norepinephrine) to maintain systolic blood pressure \> 90mmHg
* AND signs of hypoperfusion (either altered mental status, cool periphery, oliguria (\< 0.5ml/kg/h for last six hours), or blood lactate \> 2 mmol/l)
* Age \> 18 years
* Written informed consent by patient or a close person or a relative if the patient is unable to give the consent on admission according to local regulations.
Exclusion Criteria:
* Postoperative patients
* Haemodynamically significant ongoing arrhythmia . (However, e.g. patient resuscitated from serious arrhythmia can be included if the arrhythmia is not ongoing at the time of detection of shock)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01374867
Study Brief:
Protocol Section:
NCT01374867