| Trial registration number
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NCT04806061 |
Full text link
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04806061
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First author
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Marlies Ostermann, PhD
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Contact
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Marlies.Ostermann@gstt.nhs.uk
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Registration date
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2021-03-19
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Recruitment status
Last imported at : March 14, 2023, midnight
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Open label
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Center
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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unclear
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Study aim
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- confirmed covid-19 positive
- admission to critical care unit
- bladder catheter in situ
- central line in place
- age ≥18y
- written informed consent to participate in the study
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Exclusion criteria
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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- stage 3 aki (as defined by kidney disease improving global outcome criteria)
- chronic kidney disease stage 4 or 5
- contraindications to nahco3 therapy (e.g. risk of serious drug interaction, systemic
metabolic alkalosis, congestive heart failure)
- urine ph > 7.5
- serum sodium >150mmol/l
- blood pressure >180/100mghg
- severe hypokalaemia (k<3.0mmol/l)
- severe hypocalcaemia (cai <0.8 mmol/l)
- pregnant or lactating and breast-feeding women
- patient is on a medication that may interact with sodium bicarbonate
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Number of arms
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Guy's and St Thomas' NHS Foundation Trust
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Inclusion age min
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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100
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Countries
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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None
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Type of patients
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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Critical disease at enrollment
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Severity scale
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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8: Critical disease at enrollment
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Total sample size
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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80
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primary outcome
Last imported at : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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urinary alkalisation
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Notes
Last imported at : March 21, 2021, 12:31 a.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 : March 21, 2021, 12:31 a.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 1213, "treatment_name": "Sodium bicarbonate", "treatment_type": "Vitamins and dietary supplements", "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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