Treatment Costs of Kidney Injury in Patients Having Heart Surgery in the UK

NCT07719569 | Not Yet Recruiting

• 2 other identifiers: 2026CAR150354746
• Study Type: observational
• Target: 4,600
• Locations: 1 country
• Sites: 1

Brief Summary

Single-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

Outcome Measures

Primary Outcomes (1)

• Overall cost of treatment in £ for the each KDIGO stage of CSA-AKI

  Based on the KDIGO clinical practice guidelines, AKI is defined in relation to the change in serum creatinine (SCr), use of RRT (Renal Replacement Therapy) and urine output. For this study, CSA-AKI is defined (modified KDIGO) as when any one of the following three criteria are met: 1. 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; or 2. An increase in SCr by ≥1.5 times from SCr value at baseline within 72 hours of surgery; or 3. Use of RRT within 7 days of surgery.

  From date each patient had surgery to the date each patient discharged from hospital, for all eligible patients who underwent surgery between 1st January 2013 and 31st December 2025 (varies from patient to patient), assessed at point of data extraction

Secondary Outcomes (6)

• Number of patients with CSA-AKI

  From date each patient had surgery to date each patient discharged from hospital, for all eligible patients who underwent surgery between 1st January 2013 and 31st December 2025 (varies from patient to patient), , assessed at point of data extraction

• Days patient spent in ICU

  From date each patient had surgery to date each patient discharged from ICU, for all eligible patients who underwent surgery between 1st January 2013 and 31st December 2025 (varies from patient to patient), assessed at point of data extraction

• Average cost of ICU stay in £ for each KDIGO CSA-AKI stage

  From date each patient had surgery to date each patient discharged from ICU, for all eligible patients who underwent surgery between 1st January 2013 and 31st December 2025 (varies from patient to patient), assessed at point of data extraction

• Length of time each patient spent in hospital in days

  From date each patient had surgery to date each patient discharged from hospital, for all eligible patients who underwent surgery between 1st January 2013 and 31st December 2025 (varies from patient to patient), assessed at point of data extraction

• Number of patients alive upon discharge from hospital

  From date each patient had surgery to date each patient discharged from hospital, for all eligible patients who underwent surgery between 1st January 2013 and 31st December 2025 (varies from patient to patient), assessed at point of data extraction

Study Arms (2)

Patients who developed AKI in their post-operative phase

Consecutive patients who have undergone cardiac surgery and who developed AKI in their post-operative phase will be selected

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

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients undergoing elective or in-hospital urgent cardiac surgery requiring cardiopulmonary bypass at the participating cardiac surgery centre.

You may qualify if:

• Underwent elective or in-house urgent cardiac surgery at the Royal Wolverhampton NHS Trust between 1st January 2013 and 31st December 2025, excluding those who had surgery during 2020 and 2021 due to the confounding effect of COVID-19 on acute kidney injury incidence.
• Cardiopulmonary bypass (CPB) was utilised during the cardiac surgical procedure.
• A complete minimum dataset is available within the study databases, comprising: age, sex, history of diabetes, left ventricular ejection fraction (LVEF), surgical priority, pre-operative haemoglobin and serum creatinine (SCr) levels, type of cardiac surgery performed, CPB duration, EuroSCORE or logistic EuroSCORE, renal replacement therapy (RRT) use, and post-operative day 1 and/or day 2 and/or day 3 SCr values.

You may not qualify if:

• The procedure was performed as an emergency surgery.
• Required data fields are incomplete or unavailable.
• Surgery was performed off-pump, without the use of cardiopulmonary bypass.
• The patient was dialysis-dependent prior to surgery.
• The patient had a pre-operative estimated glomerular filtration rate (eGFR) of less than 20 mL/min/1.73 m².
• The cardiac procedure required deep hypothermic circulatory arrest (DHCA).
• The patient has exercised their right to opt out of research data use.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

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 7, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

GB (1)