Urine Alkalinisation in COVID-19
Urine Alkalinisation to Prevent AKI in COVID-19
1 other identifier
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Oct 2021
Longer than P75 for not_applicable covid19
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedJune 20, 2024
June 1, 2024
2.8 years
March 15, 2021
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
urinary alkalisation
urine pH \>7.5
10 days
Secondary Outcomes (1)
acute kidney injury
28 days
Study Arms (2)
sodium bicarbonate
EXPERIMENTALiv sodium bicarbonate 8.4%
control
EXPERIMENTALstandard care
Interventions
sodium bicarbonate 8.4% to achieve urinary pH \>7.5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Guy's & St Thomas Foundation Hospital
London, SE1 7EH, United Kingdom
Guy's & St Thomas Hospital
London, SE1 7EH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlies Ostermann, PhD
Guy's & St Thomas Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2021
First Posted
March 19, 2021
Study Start
October 15, 2021
Primary Completion
July 30, 2024
Study Completion
July 30, 2024
Last Updated
June 20, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share