EPIC-1: Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients

Sponsor
University of Cape Town (Other)
Overall Status
Completed
CT.gov ID
NCT03318055
Collaborator
(none)
343
6
4
57.2
435

Study Details

Study Description

Brief Summary

The study is a prospective, observational study of adult, non-cardiac, non-obstetric, elective surgical patients conducted over a period of one week. This large-scale clinical audit aims to assess the incidence rates of anaemia and hyperglycaemia amongst elective surgical patients in the Western Cape. A study such as this is essential in the assessment of the incidence rates of abnormal fasting blood glucose levels and reduce the risk of perioperative complications for patients. Preoperative anaemia is a modifiable risk factor and should be identified early and treated appropriately to improve patient outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Globally, one third of patients presenting for surgery will be anaemic, according to the WHO criteria. Preoperative anaemia is considered an independent risk factor for poorer patient outcomes, with increases in morbidity and mortality as well as prolonged length of hospital stay. However, the importance of this finding in the preoperative period is often overlooked and not corrected prior to surgery. The leading cause of preoperative anaemia is iron deficiency. Iron deficiency anaemia is common in developing countries and results mostly from nutritional deficiency. Poorly controlled Diabetes Mellitus (DM) is known to have an adverse effect on perioperative clinical outcomes, with an extended length of hospital stay and increased morbidity and mortality. Preoperative identification of patients with DM, provides a potential opportunity to reduce the risk of adverse surgical outcomes. Early identification of such patients could facilitate timely intervention and arrangement of appropriate perioperative and long-term follow-up. Studies have demonstrated that an elevated HbA1c (indicative of poor glycaemic control in the months preceding surgery) correlates with increased perioperative risk in known diabetics. On the day of surgery, before induction of anaesthesia, all patients will have a finger prick blood glucose level done by point of care glucometry, if there is no documented fasting blood glucose value in their ward file. In patients of unknown diabetic status, should the preoperative value be >7 mmol/l, blood will be drawn when IV access is established, for HbA1C measurement. In known diabetics, a sample will be taken for HbA1C, regardless of the preoperative fasting blood glucose level, unless there is an HbA1C measurement in the previous 3 months. However, should the patient management have been modified based on the HbA1C result, a repeat HbA1C measurement would be performed

    All patients will be assessed as part of the routine preoperative evaluation. Informed consent will be obtained by the anaesthetist from eligible patients who agree to participate in the study. On the day of surgery, prior to induction of anaesthesia the patients will receive a finger prick Hemoglobin (Hb) if they have not had a Hb result documented within the last 3 months. If the results meet the WHO criteria for anemia, a blood specimen will be collected when inserting the IV line. The blood specimen will be sent for Haemoglobin, mean cell volume, ferritin and transferrin saturation (TSAT) testing. All patients diagnosed with anemia will receive a patient information leaflet. They will also be referred to their local clinics or general practitioner for further evaluation and appropriate management.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    343 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study
    Actual Study Start Date :
    Oct 16, 2017
    Actual Primary Completion Date :
    Oct 20, 2017
    Actual Study Completion Date :
    Oct 20, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Single group study

    The study population will include patients presenting for elective surgery, who fulfil the inclusion criteria of all surgical disciplines undergoing elective surgery period during the period of the study. Inclusion Criteria: > 18 years of age Non-cardiac patients Non-obstetric patients Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of diagnosis of diabetes and anaemia [Day of surgery]

      Proportion of patients with diagnosis of diabetes and anaemia

    Secondary Outcome Measures

    1. HbA1C level [Day of surgery]

      Assessment of diabetic control

    2. Transferrin saturation [Day of surgery]

      Diagnosis of iron deficiency anaemia

    3. Serum ferritin [Day of surgery]

      Diagnosis of iron deficiency anaemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Adult, non-cardiac, non-obstetric, elective surgical patients
    Exclusion Criteria:
    • Obstetric, emergency and cardiac patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groote Schuur Hospital Cape Town Western Cape South Africa 7599
    2 Mitchells Plain Hospital Cape Town Western Cape South Africa 7599
    3 Somerset Hospital Cape Town Western Cape South Africa 7599
    4 Victoria Hospital Cape Town Western Cape South Africa 7599
    5 George Hospital George Western Cape South Africa 7599
    6 Paarl Hospital Paarl Western Cape South Africa 7599

    Sponsors and Collaborators

    • University of Cape Town

    Investigators

    • Principal Investigator: Netjhardt Marcin, MBChB, FCA, University of Cape Town
    • Principal Investigator: Francois Roodt, MBChB, FCA, University of Cape Town

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Bruce Biccard, Professor, University of Cape Town
    ClinicalTrials.gov Identifier:
    NCT03318055
    Other Study ID Numbers:
    • EPIC1
    First Posted:
    Oct 23, 2017
    Last Update Posted:
    May 14, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 14, 2018