Cost-effectiveness Analyses for the Prevention of Acute Kidney Injury in Patients Undergoing Cardiac Surgery in the UK

NCT07108634 | Withdrawn DMC

• 1 other identifier: 2025CAR140
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-centre retrospective analysis of prospectively collected data with propensity matched scoring groups (AKI v/s non-AKI). Data collection from databases (or their equivalent): PATS Dendrite, Electronic Medical Records, TD-web (results Portal), MedTrack (ICU database), iSite (Radiology), SPY (Long-term status)

Conditions

Acute Kidney Injury

Keywords

Cardiac surgery; Cardiopulmonary bypass machine

Outcome Measures

Primary Outcomes (2)

• CSA-AKI

  If there is an increase in serum creatinine (SCr) by ≥0.3 mg/dl (≥26.5 micromol/l) within 72 hours of surgery compared to the baseline value

  6 months

• CSA-AKI

  If there is an increase in SCr by ≥1.5 times from SCr value at baseline within 72 hours of surgery; or use of RRT within 7 days of surgery.

  6 months

Secondary Outcomes (10)

• CSA-AKI patient group vs non CSA-AKI patient group

  6 months

• CSA-AKI patient group vs non CSA-AKI patient group

  6 months

• CSA-AKI patient group vs non CSA-AKI patient group

  6 months

• CSA-AKI patient group vs non CSA-AKI patient group

  6 months

• CSA-AKI patient group vs non CSA-AKI patient group

  6 months

Study Arms (2)

Patients who developed AKI in their post-operative phase

Consecutive patients who have undergone cardiac surgery at the various cardiac surgery centres in the UK and who developed AKI in their post-operative phase will be selected.

Other: RenalGuard Therapy

Patients who did not develop AKI in their post-operative phase

The patients who developed AKI group will be propensity-matched 1:1 to patients who did not develop AKI

Interventions

RenalGuard Therapy OTHER

The RenalGuard Therapy® is comprised of a console, a single-use sterile IV infusion set, urine collection set and a cart. The console is a microcontroller device that has a means for measuring urine output and automatically controls the hydration infusion pump based on the measured urine output and clinician settings. The system is designed for infusion of hydration solutions only. The patient is connected to the console by the IV Infusion set connected to the patient's peripheral IV cannula and the urine collection set connected to the patient's indwelling Foley urinary catheter. The console continuously monitors urine production by measuring the weight of urine in the collection set, converts the urine weight to volume and then, automatically infuses the pre-set volume of hydration fluid to compensate for this output.

Patients who developed AKI in their post-operative phase

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who have undergone cardiac surgery at the various cardiac surgery centres in the UK and who developed AKI in their post-operative phase will be selected. This group will be propensity-matched 1:1 to patients who did not develop AKI. A total of around 8000 patients' data will be accessed to obtain approximately 4000 patients' (2,000 in each group) data for analysis.

You may qualify if:

• Patients undergoing cardiac surgery (elective or in-house urgent) from Jan 1st, 2013, to December 31st, 2023 (excluding patients during 2020 \& 2021 - due to confounding Covid-19 impact on AKI)
• Cardiopulmonary bypass machine was used during cardiac surgery
• Patient's data available in the databases (Minimum dataset required for propensity matching: age, gender, diabetes history, LVEF, priority of surgery, pre-op haemoglobin \& SCr levels, cardiac surgery performed, CPB duration, Euroscore or LogEuroscore, RRT use, post-op D1\&/or D2 \&/or D3 SCr)

You may not qualify if:

• Emergency surgery
• Patient with incomplete dataset\*
• Surgery performed without CPB
• Patients already dialysis dependent
• Patient with eGFR \<20 mL/min/1.73 m²
• Cardiac surgery requiring deep hypothermic circulatory arrest (DHCA)
• Patients previously treated with RenalGuard® Therapy
• Patient has opted-out of research (data opt-out) \* Data completeness - These variables need to be complete for the propensity matching: age, gender, diabetes history, LVEF, priority of surgery, pre-op haemoglobin \& SCr levels, cardiac surgery performed, CPB duration, Euroscore or LogEuroscore, RRT use, post-op D1\&/or D2 \&/or D3 SCr

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

New Cross Hospital

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 7, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

GB (1)