Urine Alkalinisation in COVID-19

Study Overview
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Brief Summary
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Since the outbreak of coronavirus disease 2019 (COVID-19), more than 100,000 patients have died in the United Kingdom. Acute kidney injury is common in critically ill patients with COVID-19. It is associated with a high risk of dying. At present, it is not clear how to prevent or treat kidney failure in these patients. Recent research has shown that the coronavirus can directly infect kidney issue. It uses a particular protein on the cell surface (the ACE2 receptor) for entry into cells. Entry into cells is easier if the blood is more acidic. The aim of this project is to find out whether urinary alkalisation using intravenous bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill patients with COVID-19.

Detailed Description
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Acute kidney injury (AKI) is common in patients with Coronavirus disease 2019 (COVID-19). Research has shown that the SARS-CoV-2 virus can directly infect kidney issue via the Angiotensin-converting-enzyme 2 receptor which is pH dependent. The aim of this randomised controlled feasibility study is to explore whether urinary alkalisation using intravenous bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill patients with COVID-19. Critically ill patients with COVID-19 and no AKI will be randomised to intravenous NaHCO3 8.4% versus standard care for up to 10 days.

Official Title
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Urine Alkalinisation to Prevent AKI in COVID-19

Conditions
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Covid19, Acute Kidney Injury

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: standard care


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 Age ≥18y Written informed consent to participate in the study Exclusion Criteria: 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

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium bicarbonate<br>iv sodium bicarbonate 8.4% | Drug: Sodium bicarbonate<br>* sodium bicarbonate 8.4% to achieve urinary pH >7.5<br>* Other names: sodium bicarbonate 8.4%;|
| Experimental: control<br>standard care | Drug: standard care<br>* standard care<br>* Other names: usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary alkalisation | urine pH >7.5 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | creatinine rise as defined by KDIGO criteria | 28 days |