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.

Acute Kidney Injury Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05001503
• Other study ID #: Stability UO 001 v1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Rinicare Ltd
• Contact: Eric D Carlson, MRes
• Phone: +44 (0)1615 37 59 29
• Email: eric[@]rinicare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 362
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is willing and able to give informed consent for participation in the study, including being able to receive study materials at least 24 hours prior to their planned operation,

• Patient is Male or Female, aged 18 years or above,

• Patient is due to undergo elective or urgent cardiac surgery, and who is expected to be managed on the CTCCU postoperatively,

• In the Investigator's opinion, able and willing to comply with all study requirements.

Exclusion Criteria:

• Patients undergoing emergency surgery (i.e surgery that has to take place in the next available theatre even if this is out of standard operating hours)

• Patients having ventricular assist device implantation,

• Patients receiving a heart transplant,

• Patients who would be unable to be treated by standard of care CTCCU therapies and practices,

• Patients who are receiving pre or intra-operative dialysis or haemofiltration.

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Oliguria

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Wythenshawe Hospital (Manchester University NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Rinicare Ltd	Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Howitt SH, Grant SW, Caiado C, Carlson E, Kwon D, Dimarakis I, Malagon I, McCollum C. The KDIGO acute kidney injury guidelines for cardiac surgery patients in critical care: a validation study. BMC Nephrol. 2018 Jun 25;19(1):149. doi: 10.1186/s12882-018-0946-x. — View Citation

Howitt SH, Oakley J, Caiado C, Goldstein M, Malagon I, McCollum C, Grant SW. A Novel Patient-Specific Model for Predicting Severe Oliguria; Development and Comparison With Kidney Disease: Improving Global Outcomes Acute Kidney Injury Classification. Crit Care Med. 2020 Jan;48(1):e18-e25. doi: 10.1097/CCM.0000000000004074. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Risk Reduction (ARR) of patients experiencing =3 oliguria events.	An oliguria event is defined as an hourly urine output of less than 0.5ml/kg/hr.	post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Secondary	Incidence of oliguria events during post cardiac surgery CTCCU stay	An oliguria event is defined as an hourly urine output of less than 0.5ml/kg/hr.	post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Secondary	Absolute Risk (AR), Relative Risk (RR), Relative Risk Reduction (RRR) of severe oliguria events	An severe oliguria event is defined as an hourly urine output of less than 0.3ml/kg/hr.	post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Secondary	Median length of total stay in hospital	median length of stay in hospital	post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Secondary	Change in post-operative serum creatinine concentration	Standard blood test to measure serum creatinine concentration (umol/L)	post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)