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.
1 other identifier
interventional
362
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedApril 28, 2022
April 1, 2022
1 year
July 28, 2021
April 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Incidence of oliguria events during post cardiac surgery CTCCU stay
post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Absolute Risk (AR), Relative Risk (RR), Relative Risk Reduction (RRR) of severe oliguria events
post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Median length of total stay in hospital
post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Change in post-operative serum creatinine concentration
post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Study Arms (2)
Intervention Group
EXPERIMENTALThe clinical team has access to the Stability UO software. All other care is given as standard.
Control Group
NO INTERVENTIONStandard care given.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rinicare Ltdlead
- Manchester University NHS Foundation Trustcollaborator
Study Sites (1)
Wythenshawe Hospital (Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT, United Kingdom
Related Publications (2)
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.
PMID: 31663925BACKGROUNDHowitt 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.
PMID: 29940876BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Mosca, MD
Manchester University NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 12, 2021
Study Start
May 1, 2022
Primary Completion
May 1, 2023
Study Completion
June 1, 2023
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share