Urine Alkalinisation 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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19 Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open label randomised controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sodium bicarbonate

iv sodium bicarbonate 8.4%

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

sodium bicarbonate 8.4% to achieve urinary pH \>7.5

control

standard care

Group Type EXPERIMENTAL

standard care

Intervention Type DRUG

standard care

Interventions

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Sodium bicarbonate

sodium bicarbonate 8.4% to achieve urinary pH \>7.5

Intervention Type DRUG

standard care

Intervention Type DRUG

Other Intervention Names

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sodium bicarbonate 8.4% usual care

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No