Urine Alkalinisation in COVID-19

Urine Alkalinisation to Prevent AKI in COVID-19

Since the outbreak of coronavirus disease 2019 (COVID-19), more than 100,000 patients have died in the United Kingdom. Acute kidney injury is common in critically ill patients with COVID-19. It is associated with a high risk of dying. At present, it is not clear how to prevent or treat kidney failure in these patients.

Recent research has shown that the coronavirus can directly infect kidney issue. It uses a particular protein on the cell surface (the ACE2 receptor) for entry into cells. Entry into cells is easier if the blood is more acidic.

The aim of this project is to find out whether urinary alkalisation using intravenous bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill patients with COVID-19.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19; Acute Kidney Injury
• Intervention / Treatment: Drug: Sodium bicarbonate; Drug: standard care

Detailed Description

Acute kidney injury (AKI) is common in patients with Coronavirus disease 2019 (COVID-19). Research has shown that the SARS-CoV-2 virus can directly infect kidney issue via the Angiotensin-converting-enzyme 2 receptor which is pH dependent. The aim of this randomised controlled feasibility study is to explore whether urinary alkalisation using intravenous bicarbonate is feasible and can reduce the risk of acute kidney injury in critically ill patients with COVID-19.

Critically ill patients with COVID-19 and no AKI will be randomised to intravenous NaHCO3 8.4% versus standard care for up to 10 days.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlies Ostermann, PhD; Phone Number: 83038 00442071887188; Email: Marlies.Ostermann@gstt.nhs.uk
• Study Contact Backup: Name: Nuttha Lumlertgul, PhD; Phone Number: 83038 00442071887188; Email: Nuttha.Lumlertgul@gstt.nhs.uk

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
• Age ≥18y
• Written informed consent to participate in the study

Exclusion Criteria:

• Stage 3 AKI (as defined by Kidney Disease Improving Global Outcome 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 > 7.5
• Serum sodium >150mmol/L
• Blood pressure >180/100mgHg
• Severe hypokalaemia (K<3.0mmol/L)
• Severe hypocalcaemia (Cai <0.8 mmol/L)
• Pregnant or lactating and breast-feeding women
• Patient is on a medication that may interact with sodium bicarbonate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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; iv sodium bicarbonate 8.4%	Drug: Sodium bicarbonate; sodium bicarbonate 8.4% to achieve urinary pH >7.5; Other Names: sodium bicarbonate 8.4%
Experimental: control; standard care	Drug: standard care; standard care; Other Names: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary alkalisation	urine pH >7.5	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute kidney injury	creatinine rise as defined by KDIGO criteria	28 days

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: University of Pittsburgh
• Investigators: Principal Investigator: Marlies Ostermann, PhD, Guy's & St Thomas Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2021
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

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; Kidney Diseases; Urologic Diseases; Renal Insufficiency; COVID-19; Acute Kidney Injury
• Other Study ID Numbers: GSTT COVID-AKI

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