| Trial registration number
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NCT04487990 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04487990
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First author
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Paulo Lins, MD
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Contact
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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paulo.lins@hc.fm.usp.br
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-07-27
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Recruitment status
Last imported at : June 9, 2022, 4 p.m.
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
confirmed or probable sars-cov-2 infection;
presence of acute kidney injury with indication and agreement between icu and nephrology teams for the introduction of renal continuous venous venous hemodialysis.
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Exclusion criteria
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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hypersensitivity to any of the substances used in the study (citric acid dextrosol 2.2% and unfractionated heparin);
previous diagnosis of coagulopathy or thrombophilia;
contraindication to the use of unfractionated heparin by the assistant team;
risk of citrate poisoning - (lactate> 30mg / dl, rni> 2.5, total bilirubin> 15mg / dl);
pregnancy
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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University of Sao Paulo General Hospital
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Inclusion age min
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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Brazil
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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No restriction on type of patients
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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0: No restriction on type of patients
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Total sample size
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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118
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primary outcome
Last imported at : July 1, 2022, 11 p.m.
Source : ClinicalTrials.gov
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Clotted dialyzers
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov
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Not reported
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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