Clinical trial

Urine Alkalinisation to Prevent AKI in COVID-19

Name
GSTT COVID-AKI
Description
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.
Trial arms
Trial start
2021-10-15
Estimated PCD
2024-07-30
Trial end
2024-07-30
Status
Active (not recruiting)
Treatment
Sodium bicarbonate
sodium bicarbonate 8.4% to achieve urinary pH \>7.5
Arms:
sodium bicarbonate
Other names:
sodium bicarbonate 8.4%
standard care
standard care
Arms:
control
Other names:
usual care
Size
80
Primary endpoint
urinary alkalisation
10 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open label randomised controlled trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-06-19

1 organization

2 products

2 indications

Indication
COVID-19