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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05304702
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for patients subjected to NEGBAL group are as follows:
* confirmed diagnosis of COVID-19
* PaO2/FiO2 (ratio of arterial oxygen partial pressure to fractional inspired oxygen) \<300;
* Patients over 18 years of age and
* tomographic evidence of acute pulmonary edema, defined as dilated superior vena cava, large pulmonary arteries, diffuse interstitial infiltrates with Kerley lines, and dilated right ventricle or dilated cardiac axis.
Patients subjected to NEGBAL underwent a treatment with furosemide in continuous intravenous infusion, guided by objectives: Negative Fluid Balance approach (NEGBAL).
Inclusion criteria for patients subjected to NO-NEGBAL-Control Group- are as follows:
* confirmed diagnosis of COVID-19 through real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay with samples obtained from nasopharyngeal swab or positive antinucleocapsid immunoglobulin M (IgM) antibodies;
* ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) \<300;
* age older than 18 years, and
* tomographic evidence of acute pulmonary edema, defined as dilated superior vena cava, large pulmonary arteries, diffuse interstitial infiltrates with Kerley lines, and dilated right ventricle or dilated cardiac axis.
Patients subjected to NO-NEGBAL group, did not receive NEGBAL approach as treatment.
Exclusion Criteria for both groups are as follows:
* patients with prior indication of diuretics for another reason,
* renal failure,
* cardiac failure (diagnosis by echocardiography),
* hepatic failure,
* hypernatremia or hyponatremia,
* hypotension or shock.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05304702
Study Brief:
Protocol Section:
NCT05304702