COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-3rdhgm

Welder Zamoner

welderzamoner@gmail.com

2020-05-14

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

patients over 18 years old, COVID-19 positive by the RT-PCR technique or rapid test, in mechanical ventilation, diagnosis of AKI, hydric balance positive higher then 3% of body weight, hospitalized in the ICU,vusing norepinephrine at a dose of 0.1 to 1 µg / kg / min.

Pregnant patients, patients who were on other types of dialysis support, other than HDP or HDC, that with an emergency indication for RAS, diagnosed with stage 5 chronic kidney disease or need for chronic renal replacement therapy (dialysis or transplantation) will be excluded.

2

Departamento de Clínica Médica da Faculdade de Medicina de Botucatu

18

100

Brazil

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

0

Control groups and intervention groups will be compared in relation to the prognosis (time of mechanical ventilation; ICU admission and mortality in 60 days between groups). Variables with normal distribution will be described as mean ± standard deviation and variables with non-normal distribution as median and interquartile range. Comparisons of continuous variables between the two groups will be performed using Student's t test for data with normal distribution and Mann-Whitney test for non-normal data. For the comparative analysis of categorical variables; the Chi-Square tests will be used. For comparisons of variables between groups by sessions; the mixed model of analysis of repeated measures over time with adjustment for Tukey will be used. Univariate and multivariate linear regression will be used for association with mechanical ventilation time and 60-day survival.In all tests performed; the significance level of 5% will be considered.

Not reported

[{"arm_notes": "Early indication", "treatment_id": 1102, "treatment_name": "Renal dialysis", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Standard indication", "treatment_id": 1102, "treatment_name": "Renal dialysis", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}]