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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: Stability UO

• Study Type: Interventional
• Enrollment (Anticipated): 362
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric D Carlson, MRes; Phone Number: +44 (0)1615 37 59 29; Email: eric@rinicare.com
• Study Contact Backup: Name: Stuart Grant, PhD; Phone Number: +44 (0)1615 37 59 29; Email: stuart.grant@rinicare.com

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • Wythenshawe Hospital (Manchester University NHS Foundation Trust
      • Contact: Juliette Novasio, Ph.D; Phone Number: 0161 291 5773; Email: juliette.novasio@mft.nhs.uk
      • Principal Investigator: Roberto Mosca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; The clinical team has access to the Stability UO software. All other care is given as standard.	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.
NO_INTERVENTION: Control Group; Standard care given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Rinicare Ltd
• Collaborators: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Roberto Mosca, MD, Manchester University NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (ACTUAL): August 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Renal Insufficiency; Urination Disorders; Acute Kidney Injury; Oliguria
• Other Study ID Numbers: Stability UO 001 v1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No