MOSAICC
Research type
Research Study
Full title
Evaluating the clinical and cost-effectiveness of Sodium Bicarbonate administration for critically ill patients with Acute Kidney Injury and metabolic acidosis
IRAS ID
1003836
Contact name
Irene Chang
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
Eudract number
2021-002587-44
ISRCTN Number
ISRCTN14027629
Research summary
Around 184,000 critically ill adults are admitted to critical care each year in the UK. Around half have a sudden worsening in kidney function called acute kidney injury (AKI) that happens as part of their illness. AKI causes more acid than normal to build up in the blood (a process known as acidosis), which can cause further harm.
In these patients, kidney replacement therapy (KRT) is the most commonly used treatment but it is invasive, has added risks and requires specialist staff and equipment, making it very expensive. Another option to treat patients with acidosis is to give an alkali (opposite to acid), such as sodium bicarbonate, to stop the effects of acid build-up and bring the level in the blood to normal. Sodium bicarbonate is a cheap and accessible treatment with the potential to increase survival and avoid KRT, but there is little clinical evidence to support its use in patients with acidosis and AKI.
Some recent evidence suggests that in a small group of patients who had acidosis and AKI, giving sodium bicarbonate may be beneficial, with better survival and fewer patients needing KRT, but more research is needed. We therefore intend to conduct a large clinical trial to find out whether using sodium bicarbonate to treat critically ill people with acidosis and AKI improves survival and is cost-effective for the NHS. The study will include 2,250 patients from 60 NHS critical care units across the UK. Patients will be randomly assigned to receive intravenous sodium bicarbonate or no sodium bicarbonate.
We will follow-up all patients at 28-days, 90-days and 1 year following the study. We will find out if sodium bicarbonate was more effective than not receiving sodium bicarbonate by comparing the number of patients alive in each group at 90 days. Patient recruitment will start early in autumn 2021 and end in 2024.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0228
Date of REC Opinion
24 Sep 2021
REC opinion
Further Information Favourable Opinion