NCT05001503

Controlled Trial to Demonstrate a Reduction in the Number of Oliguria Events in Patients Being Managed in a Critical Care Unit, Following Cardiac Surgery, When a Novel Oliguria Prediction Tool (STABILITY UO) is Used to Identify Patients at Risk, Compared to Standard of Care.

Pivotal Phase, Randomised Controlled Trial to Demonstrate a Reduction in the Number of Oliguria Events in Patients Being Managed in a Critical Care Unit, Following Cardiac Surgery, When a Novel Oliguria Prediction Tool (STABILITY UO) is Used to Identify Patients at Risk, Compared to Standard of Care.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Rinicare Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Acute kidney injury (AKI) is experienced by 12% of patients following surgery and in up to 50% of patients following cardiac surgery. It is associated with an increased risk of death and prolonged stay in critical care after surgery. In addition to the patient impact, AKI costs the NHS alone between £434m and £620m per year. One way that AKI is diagnosed is by looking at a patient's urine output and checking how much is produced over time. If this value is too low for a patient, they are diagnosed with oliguria. Too many of these oliguria events leads to a diagnosis of AKI. The product to be tested (Stability UO) aims to reduce the number of patients who suffer three or more oliguria events after surgery by processing the data entered by the care team and providing the care team with additional information about the patient's risk of oliguria over the next six hours. Patients over 18 who present at Manchester University NHS Foundation Trust for non-emergency cardiac surgery will be screened and asked to consent to be randomised as part of the trial. Patients undergoing certain operations and those with unsuitable medical history (e.g. patients being treated for dialysis) will not be invited to participate. The randomisation will determine if their care team has access to the Stability UO software after surgery. While the care team looks after the patients in the cardiothoracic critical care unit (CTCCU) after surgery, they will enter that the patient's weight and amount of urine passed each hour into the software and review the output. The primary questions the study will answer is if there is a difference between number of oliguria events between the two groups of patients. The study is funded by the device manufacturer: Rinicare Ltd.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	Stability UO	STABILITY UO is a standalone software, based on a Bayesian model, which quantifies the risk of an individual patient developing severe oliguria (0.3mg/kg/hr for 6 hours). The model identifies at risk patients by predicting future urine output, using only previously recorded urine output values for that individual, allowing clinicians to see the predicted risk of a patient developing severe oliguria in real time.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2021-08-12
• Last updated: 2022-04-28

Locations

1 site across 1 country: United Kingdom