Stability UO 001

• Research type

  Research Study

• Full 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

• IRAS ID

  302800

• Contact name

  Roberto Mosca

• Contact email

  Roberto.Mosca@mft.nhs.uk

• Sponsor organisation

  Rinicare Ltd

• Clinicaltrials.gov Identifier

  NCT05001503

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Acute kidney injury (AKI) is experienced by up to 50% of patients following cardiac surgery. It is associated with an increased risk of death and prolonged stay in critical care units, as well as costing the NHS between £434m and £620m per year.
  Cardiac surgery patients are prone to low urine output after surgery, termed oliguria. Too many occurences of oliguria lead to a diagnosis of AKI, so minimising the number of oliguria events in these patients will reduce the chances of AKI.

  Stability UO is a prediction model that aims to identify patients at risk of oliguria. Urine output data is entered into the software, which returns an asssessment of risk that the patient will suffer an oliguria event in the next 6 hours. The care team can then choose to amend the patient management as appropriate.
  
  Adult patients who are due to undergo non-emergeny cardiac surgery at Manchester University NHS Foundation Trust will be eligible for the study, except those undergoing certain operations and those with concurrent kidney injury. Participants will be randomised to standard of care (SoC) management on the cardiothoracic critical care unit (CTCCU) (control arm), or for the CTCCU team to have access to Stability UO predictions (intervention arm). Participants will be blinded to their arm allocation. For particiapants in the intervention arm, the amount of urine passed each hour will be entered into Stability UO and the CTCCU team will review the output.

  The primary question the study will answer is whether the use of Stability UO reduces the chances of a patient suffering oliguria events(3+). The study also aims to investigate whether the use of Stability UO can reduces the length of stay in the CTCCU and the usage of renal replacement therapy.
  
  The study is funded by the device manufacturer: Rinicare Ltd.
  Lay summary of study results: The study was closed early after recruitment of 62 patients due to changes in circumstances at the sponsoring organisation.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  21/SC/0318

• Date of REC Opinion

  21 Sep 2021

• REC opinion

  Favourable Opinion