Urine Alkalinisation to Prevent AKI in COVID-19

Guy's and St Thomas' NHS Foundation Trust

Status and phase

Unknown

Phase 3

Conditions

Covid19

Treatments

Drug: Sodium Bicarbonate 150Meq/L/D5W Inj

Study type

Interventional

Funder types

Other

Identifiers

NCT04655716

283852

Details and patient eligibility

About

The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.

Full 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.

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 (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