Urine Alkalinisation to Prevent AKI in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sodium bicarbonate

Intravenous sodium bicarbonate infusion

Group Type EXPERIMENTAL

Sodium Bicarbonate 150Meq/L/D5W Inj

Intervention Type 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.

Standard care

Standard of care by the clinical team

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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8.4% sodium bicarbonate intravenous form

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No