Urine Alkalinisation to Prevent AKI in COVID-19

Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19

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

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Sodium Bicarbonate 150Meq/L/D5W Inj

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium bicarbonate; Intravenous sodium bicarbonate infusion	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.; Other Names: 8.4% sodium bicarbonate intravenous form
No Intervention: Standard care; Standard of care by the clinical team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
ventilator-free days	ventilator-free days	up to day 28 after randomisation
hospital-free days	hospital-free days	up to day 60 after randomisation

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Marlies Ostermann, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 283852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No