Covid19
Conditions
Brief summary
The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.
Detailed description
Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.
Interventions
DRUGSodium Bicarbonate 150Meq/L/D5W Inj
Urine alkalinisation will be performed to achieve urine pH 7.5-8.5. Urine alkalinisation will be continued for up to 10 days or until patient is discharged or until primary endpoint is reached. Urine pH will be measured at point of care by dipstick.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed Covid-19 positive * Admission to Critical Care Unit * Bladder catheter in situ * Central line in place (including PICC line) * Age ≥18y * Written informed consent to participate in the study
Exclusion criteria
* Stage 3 AKI (as defined by KDIGO 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 \> 7.0 * Serum sodium \>150mmol/L * Blood pressure \>180/100mgHg * Severe hypokalaemia (K\<3.0mmol/L) * Inability to grant informed consent * Severe hypocalcaemia (Cai \<0.8 mmol/L) * Pregnant or lactating and breast-feeding women * Unwilling to use contraception * Patient is on a medication that may interact with sodium bicarbonate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention | up to 10 days after intensive care unit admission | proportion of patients treated who achieve \>50% of urine measurements above pH 7.0 over the duration of intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of days alive and free of stage 2-3 AKI (up to day 28) in each group | up to day 28 after randomisation | number of days alive and free of stage 2-3 AKI (up to day 28) in each group |
| proportion of patients developing stage 2-3 AKI | up to day 28 after randomisation | proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment) |
| ventilator-free days | up to day 28 after randomisation | ventilator-free days |
| hospital-free days | up to day 60 after randomisation | hospital-free days |
Countries
United Kingdom
Outcome results
None listed