Status:
COMPLETED
Lung Injury (Pulmonary Edema) in COVID-19: Treatment With Furosemide and Negative Fluid Balance (NEGBAL)
Lead Sponsor:
Clinica Colon
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
In COVID-19, pulmonary edema has been attributed to "cytokine storm". However, it is known that SARS-CoV-2 promotes angiotensin-converting enzyme 2 deficiency, it increases angiotensin II and this tri...
Detailed Description
In December 2019, a new coronavirus, known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan, China and spread throughout the world. In COVID-19, pulmonary edema has b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05304702
Start Date
November 28 2021
End Date
March 31 2022
Last Update
April 22 2022
Active Locations (1)
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1
Clínica Colón
Mar del Plata, Buenos Aires, Argentina, 7600