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NCT Number: NCT03318055

Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groote Schuur Hospital, Cape Town, Western Cape, South Africa

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, non-cardiac, non-obstetric, elective surgical patients

Exclusion criteria

  • Obstetric, emergency and cardiac patients

Treatment and study plan

Primary outcomes

  1. Prevalence of diagnosis of diabetes and anaemia

    Time frame: Day of surgery

    Proportion of patients with diagnosis of diabetes and anaemia

Secondary outcomes

  1. HbA1C level

    Time frame: Day of surgery

    Assessment of diabetic control

  2. Transferrin saturation

    Time frame: Day of surgery

    Diagnosis of iron deficiency anaemia

  3. Serum ferritin

    Time frame: Day of surgery

    Diagnosis of iron deficiency anaemia

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Registry information

Official study title

Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study

Acronym: EPIC-1

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 23, 2017
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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