Chronic Kidney Disease and Myocardial Injury After Non Cardiac Surgery

NCT05248451 | Unknown

• 1 other identifier: H21-00549
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Injury; Surgery; Chronic Kidney Diseases

Keywords

MINS; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cancellations of elective surgical cases for non-clinical reasons

  From June 1, 2020 to December 31, 2021

Study Arms (2)

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

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

Interventions

Not an Interventional Study OTHER

Not an Interventional Study

Normal Renal Function; Renal Dysfunction, Chronic Kidney Disease (CKD)

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Prabhakar, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Su-Yin MacDonell, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 21, 2022
• Study Start: June 22, 2021
• Primary Completion: June 22, 2023
• Study Completion: December 31, 2023
• Last Updated: February 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)