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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The clinical team has access to the Stability UO software. All other care is given as standard. |
|
| Control Group | No Intervention | Standard care given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stability UO | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric D Carlson, MRes | Contact | +44 (0)1615 37 59 29 | eric@rinicare.com | |
| Stuart Grant, PhD | Contact | +44 (0)1615 37 59 29 | stuart.grant@rinicare.com |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Mosca, MD | Manchester University NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wythenshawe Hospital (Manchester University NHS Foundation Trust | Manchester | Greater Manchester | M23 9LT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31663925 | Background | 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. | |
| 29940876 |
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|
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) |
| 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. |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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