Active not recruitingNAINTERVENTIONAL

Urine Alkalinisation in COVID-19

Doctors are studying whether giving critically ill COVID-19 patients sodium bicarbonate, which is a common medication that can make your blood less acidic, could protect their kidneys. Many people who get very sick with COVID-19 also develop acute kidney injury, which means their kidneys suddenly stop working well. This can be very serious and increases the risk of not recovering. Previous research suggests the COVID-19 virus might find it harder to infect kidney cells if the blood isn't too acidic. This study aims to find out if this treatment is a practical option and if it can lower the chance of kidney damage in these patients. Some patients will receive the treatment, while others will get standard care, to see if there's a difference.

At a glance

Status

Active not recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

15 Oct 2021

Estimated completion

30 Jul 2024

Covid19 Acute Kidney Injury

What is this study about?

When people get very sick with COVID-19, a lot of them also develop something called acute kidney injury. This means their kidneys suddenly have trouble working properly, which can be very serious and makes it harder for them to get better. At the moment, doctors aren't completely sure how to stop this kidney damage or treat it effectively once it starts.

New information has shown that the COVID-19 virus can actually get into kidney cells. It does this by using a specific 'doorway' on the cell surface. Interestingly, the virus might find it easier to get through this doorway and infect cells if the body's fluids are more acidic. This has led doctors to wonder if making the body's fluids less acidic could help protect the kidneys.

This study is looking into whether a treatment called sodium bicarbonate, which is commonly used to make fluids less acidic, can help. The main goal is to see if giving this treatment to very sick COVID-19 patients can make it less likely for them to get acute kidney injury. They also want to check if this treatment is practical and safe to give in a hospital setting. Half the patients will receive this special treatment, and the other half will get the usual care, so doctors can compare the results.

Key takeaways

This study is for very sick adult COVID-19 patients in intensive care.
It explores if a treatment called sodium bicarbonate can help protect kidneys.
COVID-19 can cause serious kidney problems.
The treatment might make it harder for the virus to infect kidney cells.
You would either get the treatment or standard care, chosen randomly.

Who may be eligible?

To be considered for this study, you would need to have COVID-19 that has been confirmed by a test and be admitted to an intensive care unit (ICU). You would also need to be at least 18 years old and have certain medical tubes already in place, such as a bladder catheter (a tube to help drain urine) and a central line (a special IV line). Importantly, you or a trusted family member would need to agree to take part in the study by giving written consent.

There are also reasons why someone might not be able to join. For example, if your kidneys are already severely damaged or if you have certain other serious health conditions like very high blood pressure, severe heart failure, or specific imbalances in your body's salts. The treatment might also not be suitable if you are pregnant or breastfeeding, or if you are taking medications that could react badly with sodium bicarbonate.

Quick self-check

Do I have confirmed COVID-19?
Am I in an Intensive Care Unit (ICU)?
Am I 18 years old or older?
Do I currently have a bladder catheter and a central line in place?
Do I have severe kidney disease (Stage 3 AKI or chronic kidney disease stage 4/5)? (If yes, you may not be eligible)
Do I have any serious heart conditions or severe chemical imbalances in my blood?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly chosen to either receive intravenous sodium bicarbonate (given through a drip into your vein) or continue with the standard medical care you would already be getting. This treatment or standard care would be given for up to 10 days while you are in the intensive care unit. During this time, doctors and nurses would closely monitor your condition, including your kidney function and other vital signs, to see how you are responding. There wouldn't be any extra visits or assessments beyond what is typically done in the ICU.

Potential risks and benefits

Participating in this study might offer a potential benefit if the sodium bicarbonate treatment helps protect your kidneys from damage due to COVID-19. However, it's also possible that the treatment won't have this effect. As with any medication, there can be potential risks or side effects with sodium bicarbonate, such as changes in your body's salt levels, which will be closely monitored by the medical team. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Guy's & St Thomas Foundation Hospital
London, United Kingdom
Guy's & St Thomas Hospital
London, United Kingdom

Common questions

What is 'acute kidney injury'?

It means your kidneys suddenly stop working as well as they should. This can be serious but is often temporary if treated.

What is sodium bicarbonate?

It's a common substance that can help make your body's fluids less acidic. It's often used in medicine.

Why might making my body less acidic help?

New research suggests the COVID-19 virus might find it harder to infect kidney cells if your body's pH balance is less acidic.

Will I definitely get the new treatment?

No, you'll be randomly assigned to either receive the sodium bicarbonate treatment or the standard medical care you would normally get.

How long will the treatment last?

If you receive the treatment, it will be given through a drip for up to 10 days while you are in the intensive care unit.