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The role of early dialysis in the evolution of patients with COVID19

The role of early acute renal support in the prognosis of patients diagnosed of COVID-19: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3rdhgm
Enrollment
Unknown
Registered
2020-05-14
Start date
2020-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus infection, unspecified

Interventions

When renal acute support is indicated, patients will be submitted to a block randomization process through the Randomization.com website and allocated into 2 groups: Early Indication Group: indication
Standard indication Group: RAS indication when the presence of demand and renal capacity imbalance is identified. Within each group a second randomization will be performed: Prolonged Intermittent Hem
Continuous venovenous hemodialysis (HDC): defined as a 24-hour continuous treatment that uses blood and dialysate flows between 100-150 mL / min and 1000-1500 mL / hour, respectively. Regional anticoa
Procedure/surgery

Sponsors

Departamento de Clínica Médica da Faculdade de Medicina de Botucatu
Lead Sponsor
Faculdade de Medicina de Botucatu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Dialysis dose received, by calculating kt / V based on the urea kinetics model;metabolic control and volume ;removal of cytokines, assessed by quantifying cytokines in blood sample and dialysis effluent at the beginning and end of therapy;dialysis complications

Countries

Brazil

Contacts

Public ContactWelder Zamoner

Departamento de Clínica Médica da Faculdade de Medicina de Botucatu

welderzamoner@gmail.com55-11-997636310

Outcome results

None listed

Source: REBEC (via WHO ICTRP)