RecruitingInterventional

Multicentre evaluation of sodium bicarbonate in acute kidney injury in critical care (MOSAICC)

When people become very unwell in an intensive care unit (ICU), their kidneys can suddenly stop working properly. This is called acute kidney injury. It often causes a harmful build-up of acid in the blood. Currently, doctors often use dialysis to clean the blood and remove acid, but dialysis is invasive and carries risks. This trial, called MOSAICC, tests whether giving a simple, alkaline medicine called sodium bicarbonate through a drip can neutralise this acid safely. Patients are randomly chosen to receive either sodium bicarbonate or standard care without it. Researchers will track patients for up to a year using NHS records and two short questionnaires. The goal is to see if sodium bicarbonate improves survival, reduces the need for dialysis, and provides good value for the NHS.

At a glance

Status

Recruiting

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Enrolment target

1,672

Start

12 Apr 2022

Estimated completion

30 Sep 2027

Critically ill patients with metabolic acidosis and acute kidney injury

What is this study about?

When someone is admitted to an intensive care unit (ICU), their body is under severe stress. In many cases, their kidneys suddenly slow down or stop working. This sudden problem is known as acute kidney injury. One major consequence of this injury is that acid can build up quickly in the bloodstream, a condition called metabolic acidosis. High acid levels can affect how well the heart and other organs work, making recovery much harder.

At present, the most common way to treat this acid build-up is with kidney replacement therapy, often called dialysis. Dialysis uses a specialist machine to filter and clean the blood. While it can be life-saving, it is an invasive procedure that requires special tubes placed into large veins, carries risks of infection and bleeding, and needs dedicated staff and equipment. This makes it demanding for the patient and costly for the NHS.

Another treatment option is sodium bicarbonate. Sodium bicarbonate is an alkali—the chemical opposite of an acid. Giving it through a vein can quickly help balance blood acid levels. It is already a widely used, inexpensive medicine in the NHS, but doctors do not yet have clear scientific proof that using it routinely in acute kidney injury improves survival or helps patients avoid dialysis.

The MOSAICC trial aims to provide a clear answer. By comparing patients who receive sodium bicarbonate with those who do not, the researchers hope to find out whether this simple treatment helps more people survive critical illness, lowers the need for dialysis, and improves long-term quality of life.

Key takeaways

The MOSAICC trial investigates if sodium bicarbonate helps critically ill patients with sudden kidney problems.
It aims to find out whether balancing blood acid levels reduces the need for invasive dialysis machines.
Patients in about 60 UK intensive care units are randomly allocated to receive the medicine or standard care.
Safety risks are no greater than standard care, and patients are monitored around the clock by ICU staff.
Follow-up lasts for one year through routine NHS records and two brief quality-of-life surveys.

Who may be eligible?

This trial is designed for adults aged 18 and older who are currently being treated in an NHS intensive care unit. Because of the nature of the study, patients cannot sign up directly from home; doctors and nurses in participating hospitals identify eligible patients.

To be eligible, a patient must have acute kidney injury (moderate to severe sudden kidney damage) and metabolic acidosis (acid levels in the blood that are higher than normal). Doctors confirm this using routine tests, such as checking creatinine levels in blood tests and measuring how much urine the kidneys are producing.

Patients who are already receiving dialysis or who have specific medical reasons why sodium bicarbonate would not be safe will not be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

The patient is aged 18 or over.
The patient is currently being cared for in an NHS intensive care unit (ICU).
The patient has been diagnosed with sudden, moderate to severe kidney injury (AKI).
Blood tests show higher-than-normal acid levels in the blood (metabolic acidosis).
The patient is being treated at a participating NHS hospital trust.

Answer every question to see your result.

What does participation involve?

Taking part in this study happens entirely while the patient is in the intensive care unit, with no extra hospital visits required after going home. Eligible patients are randomly placed into one of two groups by a computer. One group receives sodium bicarbonate liquid given directly into a vein through a drip, while the other group receives standard intensive care without sodium bicarbonate.

All patients continue to receive full, high-quality medical care from the ICU team. The doctors and nurses monitor blood tests, heart rate, and kidney function very closely throughout the hospital stay. Once a patient leaves hospital, researchers will track their health through routine NHS records up to 90 days. The study team will also post or email a short questionnaire at 90 days and again at one year to ask about recovery, daily activities, and quality of life. The total follow-up time for the study is one year.

Potential risks and benefits

Patients who receive sodium bicarbonate may benefit from having their blood acid levels corrected quickly, which could potentially reduce the strain on their kidneys and lower the chance of needing dialysis. However, there is no guarantee of direct benefit. Sodium bicarbonate is a standard medicine already used across the NHS, and safety regulators have confirmed that taking part carries no higher risk than normal hospital care. Possible side effects include changes in blood salts or fluid balance, which the intensive care team monitors and manages closely. Taking part is completely voluntary. Patients or their families have the right to withdraw from the study at any point without giving a reason, and doing so will not affect the standard of medical care they receive.

Locations (3)

Royal Surrey County Hospital
Approximate
Guildford, England
Royal Derby Hospital
Approximate
Derby, England
Worthing Hospital
Approximate
Worthing, England

Common questions

What is sodium bicarbonate?

Sodium bicarbonate is a safe, alkaline solution commonly used in medicine. It works by neutralising excess acid in the blood, helping to restore a healthy chemical balance.

How is it decided which treatment a patient gets?

A computer programme randomly decides whether a patient receives sodium bicarbonate or standard care. This random choice ensures the test is fair and unbiased.

What happens if a patient is too ill to give consent?

Because people in intensive care are often sedated or very sick, researchers follow strict NHS ethical rules. They will consult family members or an independent doctor before enrolling the patient, and the patient will be asked for their own consent once they recover.

Will taking part require extra hospital visits?

No. All treatments and initial checks take place during the normal ICU stay. After discharge, researchers collect health updates through routine NHS records and two postal or online surveys.

Does this trial stop patients from getting dialysis if they need it?

No. The medical team will always provide dialysis or any other emergency treatment if they believe it is necessary for the patient's safety and recovery.

How to find out more

Study Team

MOSAICC@icnarc.org None provided Official trial record

Always speak to your GP or specialist before deciding to take part in a study.