Urine Alkalinisation to Prevent AKI in COVID-19

NCT04655716 | Unknown Phase 3

• 1 other identifier: 283852
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  up to day 28 after randomisation

• ventilator-free days

  up to day 28 after randomisation

• hospital-free days

  up to day 60 after randomisation

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

Intravenous sodium bicarbonate infusion

Drug: Sodium Bicarbonate 150Meq/L/D5W Inj

Standard care

NO INTERVENTION

Standard of care by the clinical team

Interventions

Sodium Bicarbonate 150Meq/L/D5W Inj DRUG

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.

Also known as: 8.4% sodium bicarbonate intravenous form

Sodium bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marlies Ostermann

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 7, 2020
• Study Start: July 19, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)