search
Back to results

Urine Alkalinisation in COVID-19

Primary Purpose

Covid19, Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sodium bicarbonate
standard care
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    sodium bicarbonate

    control

    Arm Description

    iv sodium bicarbonate 8.4%

    standard care

    Outcomes

    Primary Outcome Measures

    urinary alkalisation
    urine pH >7.5

    Secondary Outcome Measures

    acute kidney injury
    creatinine rise as defined by KDIGO criteria

    Full Information

    First Posted
    March 15, 2021
    Last Updated
    March 17, 2021
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
    Collaborators
    University of Pittsburgh
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04806061
    Brief Title
    Urine Alkalinisation in COVID-19
    Official Title
    Urine Alkalinisation to Prevent AKI in COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2021 (Anticipated)
    Primary Completion Date
    May 15, 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
    Collaborators
    University of Pittsburgh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    open label randomised controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sodium bicarbonate
    Arm Type
    Experimental
    Arm Description
    iv sodium bicarbonate 8.4%
    Arm Title
    control
    Arm Type
    Experimental
    Arm Description
    standard care
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium bicarbonate
    Other Intervention Name(s)
    sodium bicarbonate 8.4%
    Intervention Description
    sodium bicarbonate 8.4% to achieve urinary pH >7.5
    Intervention Type
    Drug
    Intervention Name(s)
    standard care
    Other Intervention Name(s)
    usual care
    Intervention Description
    standard care
    Primary Outcome Measure Information:
    Title
    urinary alkalisation
    Description
    urine pH >7.5
    Time Frame
    10 days
    Secondary Outcome Measure Information:
    Title
    acute kidney injury
    Description
    creatinine rise as defined by KDIGO criteria
    Time Frame
    28 days

    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marlies Ostermann, PhD
    Phone
    00442071887188
    Ext
    83038
    Email
    Marlies.Ostermann@gstt.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nuttha Lumlertgul, PhD
    Phone
    00442071887188
    Ext
    83038
    Email
    Nuttha.Lumlertgul@gstt.nhs.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marlies Ostermann, PhD
    Organizational Affiliation
    Guy's & St Thomas Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Urine Alkalinisation in COVID-19

    We'll reach out to this number within 24 hrs