Urine Alkalinisation to Prevent AKI in COVID-19

Study Overview
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Brief Summary
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The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.

Detailed Description
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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.

Official Title
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Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: Sodium Bicarbonate 150Meq/L/D5W Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed Covid-19 positive Admission to Critical Care Unit Bladder catheter in situ Central line in place (including PICC line) Age ≥18y Written informed consent to participate in the study Exclusion Criteria: Stage 3 AKI (as defined by KDIGO 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 > 7.0 Serum sodium >150mmol/L Blood pressure >180/100mgHg Severe hypokalaemia (K<3.0mmol/L) Inability to grant informed consent Severe hypocalcaemia (Cai <0.8 mmol/L) Pregnant or lactating and breast-feeding women Unwilling to use contraception Patient is on a medication that may interact with sodium bicarbonate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate<br>Intravenous sodium bicarbonate infusion | Drug: Sodium Bicarbonate 150Meq/L/D5W Inj<br>* 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.<br>* Other names: 8.4% sodium bicarbonate intravenous form;|
| No Intervention: Standard care<br>Standard of care by the clinical team | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |