Urine Alkalinisation in COVID-19

Not Applicable

Active, not recruiting

• Conditions: Covid19; Acute Kidney Injury
• Interventions: Drug: standard care; Drug: Sodium bicarbonate

• Registration Number: NCT04806061
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Study Start: 2021-10-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	standard care	standard care
sodium bicarbonate	Sodium bicarbonate	iv sodium bicarbonate 8.4%

Primary Outcome Measures

Name	Time	Method
urinary alkalisation	10 days	urine pH \>7.5

Secondary Outcome Measures

Name	Time	Method
acute kidney injury	28 days	creatinine rise as defined by KDIGO criteria

Trial Locations

Locations (2)

Guy's & St Thomas Foundation Hospital; 🇬🇧 London, United Kingdom

Guy's & St Thomas Hospital; 🇬🇧 London, United Kingdom