Acute Kidney InjuryNCT05001503
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.
A study testing Stability UO in people with Acute Kidney Injury, run by Rinicare Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Stability UO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wythenshawe Hospital (Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT
Juliette Novasio, Ph.D, 0161 291 5773, juliette.novasio@mft.nhs.uk
Roberto Mosca, MD
About this study
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.
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.
Read more
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
- Being tested
- Stability UO
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stability UODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The clinical team has access to the Stability UO software. All other care is given as standard. Receives: Device: Stability UO |
| Control Group | No intervention | Standard care given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
An oliguria event is defined as an hourly urine output of less than 0.5ml/kg/hr.
Measured: 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.
Measured: 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
Measured: 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)
Measured: post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rinicare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Roberto Mosca, MD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001503
- Sponsor's protocol ID
- Stability UO 001 v1.0
- Status last verified
- Apr 2022
- First submitted
- 28 Jul 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31663925Howitt 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.
PubMed 29940876
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05001503
- Acronym / sponsor ID
- Stability UO 001 v1.0
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Rinicare LtdIndustry (pharma, biotech, devices)
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Stability UOThe clinical team has access to the Stability UO software. All other care is given as standard. |
| Control Group | No intervention | –Standard care given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stability UOSTABILITY 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. | Device | Intervention Group |
Primary outcome
Absolute Risk Reduction (ARR) of patients experiencing ≥3 oliguria events.
Time frame: post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
An oliguria event is defined as an hourly urine output of less than 0.5ml/kg/hr.
4 secondary outcomes
Incidence of oliguria events during post cardiac surgery CTCCU stay
Time frame: 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
Time frame: post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Median length of total stay in hospital
Time frame: post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Change in post-operative serum creatinine concentration
Time frame: post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 31663925Howitt 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.
- Background: PubMed 29940876Howitt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Mosca, MD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stability UO in people with Acute Kidney Injury, run by Rinicare Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric D Carlson, MRes (+44 (0)1615 37 59 29, eric@rinicare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Risk Reduction (ARR) of patients experiencing ≥3 oliguria events. (time frame: post cardiac surgery CTCCU stay (average 2-5 days with some staying more than 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05001503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.