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Urine Alkalinisation to Prevent AKI in COVID-19

Primary Purpose

Covid19

Status
Active
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Sodium Bicarbonate 150Meq/L/D5W Inj
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guy's & St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sodium bicarbonate

Standard care

Arm Description

Intravenous sodium bicarbonate infusion

Standard of care by the clinical team

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
ventilator-free days
ventilator-free days
hospital-free days
hospital-free days

Full Information

First Posted
December 4, 2020
Last Updated
March 14, 2022
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04655716
Brief Title
Urine Alkalinisation to Prevent AKI in COVID-19
Official Title
Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
Intravenous sodium bicarbonate infusion
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard of care by the clinical team
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate 150Meq/L/D5W Inj
Other Intervention Name(s)
8.4% sodium bicarbonate intravenous form
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
Description
proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention
Time Frame
up to 10 days after intensive care unit admission
Secondary Outcome Measure Information:
Title
number of days alive and free of stage 2-3 AKI (up to day 28) in each group
Description
number of days alive and free of stage 2-3 AKI (up to day 28) in each group
Time Frame
up to day 28 after randomisation
Title
proportion of patients developing stage 2-3 AKI
Description
proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment)
Time Frame
up to day 28 after randomisation
Title
ventilator-free days
Description
ventilator-free days
Time Frame
up to day 28 after randomisation
Title
hospital-free days
Description
hospital-free days
Time Frame
up to day 60 after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlies Ostermann
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's & St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Urine Alkalinisation to Prevent AKI in COVID-19

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