Chronic Kidney Disease and Myocardial Injury After Non Cardiac Surgery (MINS)

The Impact of Chronic Kidney Disease on Risk of Myocardial Injury After Non Cardiac Surgery (MINS). A Retrospective Chart Review.

Investigators will conduct a retrospective chart review, examining the impact of chronic kidney disease on risk of myocardial injury after non cardiac surgery (MINS). The objective of this study is to examine interactions between preoperative Estimated Glomerular Filtration Rate (eGFR) and the association between preoperative N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) and post operative cardiac events in patients undergoing major non cardiac surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Injury; Chronic Kidney Diseases; Surgery
• Intervention / Treatment: Other: Not an Interventional Study

Detailed Description

In recent years some authors have shown a correlation between increased post operative troponin and increased 30 day mortality in patients with kidney disease that mirrors the known correlation in those with normal renal function. In patients undergoing non cardiac surgery, Walsh et al demonstrated a 4 to 6 fold increased risk of death associated with elevated post operative troponin in patients with reduced (<60 ml/min, but >30ml/min) preoperative estimated glomerular filtration rate (eGFR). A second, more recent study by Liem et al, also found post operative troponin elevations were associated with higher morbidity and mortality risk in patients with chronic kidney disease undergoing non cardiac surgery. Investigators aim to build upon the findings of these authors by examining the relationship between pre operative eGFR, post operative troponin and risk of post operative cardiac events in patients undergoing non cardiac surgery at St Paul's hospital. Investigators will conduct a retrospective chart review of electronic records for all patients undergoing non cardiac, inpatient surgery at St Paul's Hospital from June 1, 2020 to December 31, 2021). Investigators will include all patients for whom preoperative eGFR values are available, and patients on chronic dialysis. Patients are to be stratified by preoperative eGFR and primary outcomes compared between patients with normal vs abnormal preoperative eGFR. Primary outcomes to be reviewed are myocardial injury after non cardiac surgery (MINS) and troponin elevations.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing non cardiac surgery at St Paul's hospital.

Description

Inclusion Criteria:

• Patients undergoing non cardiac surgery, at St Paul's Hospital, during the period spanning June 1 2020 to November 30 2020
• Preoperative eGFR data is available, or chronic dialysis status is known (these patients will not reliably have eGFR measured, and it is not relevant)
• Inpatient surgeries (elective, urgent, and emergent)

Exclusion Criteria:

• Patients undergoing cardiac surgery.
• Patients undergoing day surgery
• Patients for whom Estimated Glomerular Filtration Rate (eGFR) results are not available

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Renal Function; Patients undergoing inpatient non-cardiac surgery at St. Paul's Hospital with normal preoperative Estimated Glomerular Filtration Rate (eGFR) results. eGFR values considered will be from samples drawn within a one year period preceding surgery. Values from samples drawn within the 7 days immediately preceding surgery will be excluded, in order to avoid introducing bias from acute kidney injuries. All available eGFR values in the 7 to 365 days preceding an individual's surgery will be included, and the average of these values will be used as their preoperative eGFR. Investigators will include all people that have one or more measure. Depending on sample size, investigators may decide to limit inclusion to those that have two or more eGFR estimates.	Other: Not an Interventional Study; Not an Interventional Study
Renal Dysfunction, Chronic Kidney Disease (CKD); Patients undergoing non-cardiac surgery with abnormal preoperative Estimated Glomerular Filtration Rate (eGFR). eGFR values considered will be from samples drawn within a one year period preceding surgery. Values from samples drawn within the 7 days immediately preceding surgery will be excluded, in order to avoid introducing bias from acute kidney injuries. All available eGFR values in the 7 to 365 days preceding an individual's surgery will be included, and the average of these values will be used as their preoperative eGFR. Investigators will include all people that have one or more measure. Depending on sample size, investigators may decide to limit inclusion to those that have two or more eGFR estimates. As eGFR is not accurate in the setting of dialysis, patients receiving dialysis for at least 90 days prior to their surgical procedure will also be included as a separate eGFR category.	Other: Not an Interventional Study; Not an Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial injury after non cardiac surgery (MINS)	Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions	Within 30 days post-operatively
Troponin Elevation	Post-operative high sensitivity Troponin T (hs-TnT) of 20 ng/L to 65 ng/L with an absolute increase of at least 5 ng/L or any concentration > 65 ng/L	Postoperative day 1 - 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancellations of elective surgical cases for non-clinical reasons	Cancellations of elective surgical cases due to COVID-19 implications or staffing issues.	From June 1, 2020 to December 31, 2021

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Christopher Prabhakar, MD, University of British Columbia; Principal Investigator: Su-Yin MacDonell, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Anticipated): June 22, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 11, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; MINS
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Wounds and Injuries
• Other Study ID Numbers: H21-00549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No