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Urine Alkalinisation to Prevent AKI in COVID-19

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04655716
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
17.4
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium Bicarbonate 150Meq/L/D5W Inj
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Urine Alkalinisation to Prevent Acute Kidney Injury in COVID-19
Actual Study Start Date :
Jul 19, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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]

      proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention

    Secondary Outcome Measures

    1. number of days alive and free of stage 2-3 AKI (up to day 28) in each group [up to day 28 after randomisation]

      number of days alive and free of stage 2-3 AKI (up to day 28) in each group

    2. proportion of patients developing stage 2-3 AKI [up to day 28 after randomisation]

      proportion of patients developing stage 2-3 AKI (or stage 3 if already at stage 2 at enrollment)

    3. ventilator-free days [up to day 28 after randomisation]

      ventilator-free days

    4. hospital-free days [up to day 60 after randomisation]

      hospital-free days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guy's & St Thomas' NHS Foundation Trust London United Kingdom

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT04655716
    Other Study ID Numbers:
    • 283852
    First Posted:
    Dec 7, 2020
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 15, 2022