Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
NCT ID: NCT04530448
Last Updated: 2023-12-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
3 participants
INTERVENTIONAL
2020-10-05
2021-07-15
Brief Summary
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Detailed Description
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One relatively simple approach would be to perturb the ability of the RBD to bind to its cellular (hACE2) receptor. Changes in pH may cause each amino acid residue, in the RBD, to assume a slightly different 'microscopic' conformation-dependent pKa value. Urine pH is normally 5.5- 6.5 (not too dissimilar to alveolar fluid-6.4-6.86) and can be easily and safely manipulated. In fact, urine alkalinization protocols have been used for decades to reduce renal toxicity from various compounds (especially chemotherapy) and are recommended by US and European toxicology societies. Here, the strategy will be deployed not for ion trapping but to inhibit the virus from infecting RTEC. Alkalinizing the urine using IV sodium-bicarbonate solution to pH of 7.5 or more can be easily and safely achieved.
While severe AKI does not appear to be a major part of the SARS-CoV-2 syndrome for most patients, when severe AKI does occur, mortality is very high and preventing early AKI may reduce AKI severity as the disease progresses.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Group 2 (treatment) will receive sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour.
TREATMENT
NONE
Study Groups
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Standard of Care
Standard of Care treatment
Standard of Care
Standard of Care treatment
Sodium Bicarbonate
Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.
Sodium bicarbonate
Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.
Interventions
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Sodium bicarbonate
Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.
Standard of Care
Standard of Care treatment
Eligibility Criteria
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Inclusion Criteria
* Admission to ICU or step-down unit
* Age ≥ 18 years old
Exclusion Criteria
* CKD stage 4-5
* Contraindications to Na bicarbonate therapy (e.g. met. alkalosis, severe heart failure)
* Urine pH \> 7.0
18 Years
ALL
No
Sponsors
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West Virginia University
OTHER
Responsible Party
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Principal Investigators
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Ankit Sakhuja, MD
Role: PRINCIPAL_INVESTIGATOR
West Virginia University
Locations
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WVU Medicine Heart & Vascular Institute
Morgantown, West Virginia, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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UNITED STATES RENAL DATA SYSTEM
Other Identifiers
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2005006707
Identifier Type: -
Identifier Source: org_study_id