Myocardial Injury After Radical Nephrectomy

NCT06515431 | Withdrawn

• 1 other identifier: STH22687
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney removal for cancer (nephrectomy) is a major operation. People can develop heart complications during or after surgery, especially if they are older or already have heart disease. One form of heart damage is called myocardial injury (MINS). This can be detected with a simple and easily available blood test. Unlike a heart attack, MINS doesn't cause changes in the electrical tracing of the heart (ECG) and it typically doesn't cause symptoms like pain. However, it can lead to heart problems and a stroke after surgery. We do not know how many people having a nephrectomy develop MINS. It is important to know if people are at high risk of MINS to help decide future treatment. There are a few different ways of carrying out nephrectomy surgery. These can be traditional open surgery, keyhole surgery or robotic surgery. We know that MINS is more likely if there has been a lot of bleeding during the operation, but other factors are also important. Therefore, it's important to monitor the relationship between blood loss, rates of MINS and method of surgery. We aim to recruit 120 participants undergoing nephrectomy to see how many develop MINS and to compare blood loss between different ways of surgery. Patients will be asked to consent to have blood tests on the day of and the day after surgery. This test will be added to routine hospital blood tests (and so no extra samples are needed). These results will show how many patients are diagnosed with MINS after nephrectomy. Around 90 days after the surgery, their quality of life and any further heart or breathing problems will also be recorded. We hope to identify the rates of and risk factors for MINS, so future patients can be spared this complication of surgery.

Conditions

Myocardial Injury

Outcome Measures

Primary Outcomes (1)

• Proportion of patients undergoing radical nephrectomy with evidence of myocardial injury (MINS)

  This will be defined as a raised troponin level \>99th percentile upper reference limit on any sample taken within 72 hours following the operation.

  72 hours post surgery

Secondary Outcomes (4)

• Occurrence of intraoperative and post-operative blood transfusion

  72 hours post surgery

• Number of days out of hospital

  90 days post surgery

• Rate of major adverse cardiac events (MACE)

  90 days post surgery

• Impact on quality of life, assessed by EQ-5D-5L questionnaire completed by patients

  90 days post surgery

Study Arms (2)

Laparoscopic nephrectomy

Robotic nephrectomy

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

Surgery waiting lists will be screened by members of the research team at Sheffield Teaching Hospitals to identify patients that will be undergoing a radical nephrectomy for suspected renal cancer. The surgical approach will already have been decided before the study is introduced. Those eligible will be contacted via phone to discuss the study further.

You may qualify if:

• Adult patients (aged 18 and above)
• Undergoing a radical nephrectomy (either laparoscopic or robotic) for suspected renal cancer
• Stage \<T3a
• Can provide informed consent

You may not qualify if:

• Patients under 18
• Undergoing partial nephrectomy
• Undergoing radical nephrectomy not for suspected renal cancer
• Unable to provide informed consent

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: April 16, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)