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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT03206658
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years of age
* Patients critically ill requiring invasive mechanical ventilation with some organic failure in addition to respiratory failure.
Organic scale failure will be categorized according to the (Sequential Organ Failure Assesment) scale and will be considered present when there is a score ≥2 in some organ / system, except renal.
* Patients with normal renal function or chronic kidney disease KDOQI 1-3
* Patients without acute renal injury according to the (acute kidney injury network) AKIN criteria.
* Normal serum K levels (less than or equal to 5 mEq / L).
* Women with (a) negative pregnancy test, (b) surgical sterilization, or (c) completed menopause.
* Systolic blood pressure\> 90 mmHg and mean arterial pressure\> 70 mmHg.
* Diuresis in the first 6 hrs from admission to intensive therapy\> 0.5 ml / kg / hr.
* The patient will give written and signed informed consent prior to any specific study procedure. However, if a patient can not do so before, his or her legal representative the Institute may give written informed consent.
Exclusion Criteria:
* Patients with chronic kidney disease stages 4-5 of KDOQI / renal replacement therapy.
* Patients with acute kidney injury according to the AKIN criteria at the time of admission to the intensive care unit
* Patients with refractory septic shock, defined as a state of hypotension requiring administration of ≥0.25 mcg / kg / min of noradrenaline.
* Patients with known adrenal insufficiency.
* Patients with indication for the administration of angiotensin-converting enzyme (ACE) blockers or angiotensin 2 receptor antagonists.
* Known allergy to spironolactone.
* Contraindication for orally medication or placement of any probe (SNG or SNE)
* It is considered that the patient is unlikely to survive the study period (30 days) or has a disease of rapid or terminal progression.
* The patient is participating in any other clinical trial involving the administration of a research drug at the time of the presentation during the course of the study or has been treated with a research drug within 30 days prior to enrollment.
* The patient has been enrolled in this study previously.
* The patient is pregnant or breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03206658
Study Brief:
Protocol Section:
NCT03206658