The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes
The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are:
- What is the prevalence of hyperglycemia in surgical patients with prediabetes?
- What is the relative risk of postoperative complications associated with hyperglycemia?
To answer these questions, surgical patients with prediabetes will undergo universal glucose measurement in the perioperative period. Glucose data will be analyzed in conjunction with electronic health record (EHR) data describing patient outcomes.
Panoramica dello studio
Stato
Descrizione dettagliata
Background
Day-of-surgery and postoperative ('perioperative') hyperglycemia are modifiable risk factors for complications after non-cardiac surgery, including surgical site infections, 30-day readmissions, and mortality. Data from Alberta suggests perioperative hyperglycemia is common among people without diabetes, affecting about 13% of people with prediabetes on the day-of-surgery and 18% of people without diabetes after surgery. Paradoxically, the risks of perioperative hyperglycemia appear to be two-times greater for people with prediabetes than for people with diabetes and the reasons for this are unknown. Current estimates of the prevalence of perioperative for people with prediabetes are limited. Understanding the true prevalence would inform individual decision-making around surgery, the need for further research about the true association of hyperglycemia and adverse outcomes, and clinical decisions about the utility of measuring glucose for all people with prediabetes around the time of surgery.
Objectives
This prospective cohort study will establish the prevalence of perioperativehyperglycemia in people with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries. This information will inform:
- Patients, to better understand their individual risks of elective surgery.
- Clinicians, on the need for perioperative glucose measurement for patients with prediabetes.
- Researchers, on the need for and design of further studies.
Methods Overview
We will measure glucose in all adult patients with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries throughout the perioperative period (referring to the day of surgery and up to the first 3 postoperative days or discharge, whichever comes first) to determine the prevalence of perioperative dysglycemia in people with prediabetes.
This project will leverage established data sources and linkages to address secondary and exploratory objectives: (1) Use in-hospital insulin prescribing data to describe current practices for treatment of perioperative hyperglycemia in people with prediabetes; (2) Explore the association between clinical outcomes like infections and length of stay with perioperative hyperglycemia in people with prediabetes; and (3) Compare the prevalence of perioperative hyperglycemia and the association of hyperglycemia with clinical outcomes between the intervention period and a historical control period (pre-intervention at the same hospital) and a contemporaneous, non-intervention site (UAH, Edmonton) to examine whether the 'prediabetes paradox' is a result of confounding by indication or another cause.
Outcomes
If the prevalence of perioperative hyperglycemia in people with prediabetes is sufficiently high, clinical guidelines should recommend perioperative glycemic monitoring for patients with prediabetes. Further, if there is an association between hyperglycemia and adverse outcomes, intervention-based studies are needed to determine whether this risk is modifiable with hyperglycemia treatment.
Team
The NPI and co-investigators have led a 5-year implementation science and quality improvement study to improve perioperative glycemic management for people with diabetes in Alberta. This interdisciplinary group of patients, nurses, endocrinologists, surgeons, anesthesiologists, internists, and implementation scientists will leverage their existing data access, professional networks, and content expertise to conduct this study.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Shannon Ruzycki, MD
- Numero di telefono: +1 (403) 604-1642
- Email: shannon.ruzycki@ucalgary.ca
Luoghi di studio
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Alberta
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Calgary, Alberta, Canada
- Foothills Medical Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Hemoglobin A1c measurement between 6 and 6.4%
- Scheduled for non-cardiac surgery
Exclusion Criteria:
- Age>18
- Pregnancy
- Any formal diabetes diagnosis
- Current use of medications that influence blood glucose regardless of the indication
- Undergoing cardiac, intracranial neurosurgery, bariatric, or pancreatic surgeries
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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Surgical Patients with Prediabetes
Adult patients undergoing non-cardiac surgeries who have pre-diabetes.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prevalence of perioperative hyperglycemia
Lasso di tempo: Up to the first 3 postoperative days or discharge, whichever comes first.
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Prediabetes will be defined as described in Section 4.2 using Diabetes Canada definitions.
The perioperative period will include the day of surgery and the early postoperative period.
The day of surgery includes surgical admitting, intraoperative, and recovery room on postoperative day (POD) 0, which is the day that surgery was completed until 23:59.
The early postoperative period will be defined as the first 3 full postoperative days, in keeping with studies that have demonstrated that hyperglycemia is most common in the first 72 hours after surgery and that early hyperglycemia is associated with greater 30-day postoperative mortality.
Hyperglycemia will be defined using Diabetes Canada reference ranges as any glucose value >10.0 mmol/L by any form of glucose measurement.
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Up to the first 3 postoperative days or discharge, whichever comes first.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Post-operative complications
Lasso di tempo: Within 30 days of surgery.
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Postoperative complications are defined in accordance with the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), a standardized list of preventable complications developed by surgeons and used internationally to describe hospital-level quality of surgical care.
These include the following adverse events within 30 days of surgery: SSIs (superficial, deep incisional, organ/space, using the Centres for Disease Control definitions), wound dehiscence, pneumonia, unplanned intubation, pulmonary embolism, ventilator use >48 hours, acute renal failure, urinary tract infection, stroke, cardiac arrest, myocardial infarction, transfusion complications, deep vein thrombosis, sepsis, septic shock, Clostridium difficile infection, death, readmissions, and unplanned reoperations.
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Within 30 days of surgery.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Shannon Ruzycki, MD, University of Calgary
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REB26-0116
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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