Urine Alkalinisation to Prevent AKI in COVID-19

Covid19 Clinical Trial

Official title:

Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655716
• Other study ID #: 283852
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 19, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Sodium 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.

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention	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
Secondary	number of days alive and free of stage 2-3 AKI (up to day 28) in each group	number of days alive and free of stage 2-3 AKI (up to day 28) in each group	up to day 28 after randomisation
Secondary	proportion of patients developing stage 2-3 AKI	proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment)	up to day 28 after randomisation
Secondary	ventilator-free days	ventilator-free days	up to day 28 after randomisation
Secondary	hospital-free days	hospital-free days	up to day 60 after randomisation