Urine Alkalinisation to Prevent AKI in COVID-19

Phase 3

• Conditions: Covid19
• Interventions: Drug: Sodium Bicarbonate 150Meq/L/D5W Inj

• Registration Number: NCT04655716
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-07
• Study Start: 2021-07-19
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium bicarbonate	Sodium Bicarbonate 150Meq/L/D5W Inj	Intravenous sodium bicarbonate infusion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
ventilator-free days	up to day 28 after randomisation	ventilator-free days
hospital-free days	up to day 60 after randomisation	hospital-free days
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)

Trial Locations

Locations (1)

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