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The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.
Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate | Experimental | Intravenous sodium bicarbonate infusion |
|
| Standard care | No Intervention | Standard of care by the clinical team |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate 150Meq/L/D5W Inj | Drug | Urine alkalinisation will be performed to achieve urine pH 7.5-8.5. Urine alkalinisation will be continued for up to 10 days or until patient is discharged or until primary endpoint is reached. Urine pH will be measured at point of care by dipstick. |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention | proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention | up to 10 days after intensive care unit admission |
| Measure | Description | Time Frame |
|---|---|---|
| number of days alive and free of stage 2-3 AKI (up to day 28) in each group | number of days alive and free of stage 2-3 AKI (up to day 28) in each group | up to day 28 after randomisation |
| proportion of patients developing stage 2-3 AKI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlies Ostermann | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas' NHS Foundation Trust | London | United Kingdom |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
|
proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment)
| up to day 28 after randomisation |
| ventilator-free days | ventilator-free days | up to day 28 after randomisation |
| hospital-free days | hospital-free days | up to day 60 after randomisation |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |