Urine Alkalinisation in COVID-19

Guy's and St Thomas' NHS Foundation Trust

Status: Active, not recruiting

Conditions: Acute Kidney Injury; Covid19

Treatments: Drug: Sodium bicarbonate; Drug: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04806061

GSTT COVID-AKI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

sodium bicarbonate

Experimental group

Description:

iv sodium bicarbonate 8.4%

Treatment:

Drug: Sodium bicarbonate

control

Experimental group

Description:

standard care

Treatment:

Drug: standard care