Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients (EPIC-1)
Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Western Cape
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Cape Town、Western Cape、南非、7599
- Mitchells Plain Hospital
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Cape Town、Western Cape、南非、7599
- Somerset Hospital
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Cape Town、Western Cape、南非、7599
- Victoria Hospital
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Cape Town、Western Cape、南非、7599
- Groote Schuur Hospital
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George、Western Cape、南非、7599
- George Hospital
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Paarl、Western Cape、南非、7599
- Paarl Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Adult, non-cardiac, non-obstetric, elective surgical patients
Exclusion Criteria:
- Obstetric, emergency and cardiac patients
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Prevalence of diagnosis of diabetes and anaemia
大体时间:Day of surgery
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Proportion of patients with diagnosis of diabetes and anaemia
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Day of surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HbA1C level
大体时间:Day of surgery
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Assessment of diabetic control
|
Day of surgery
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Transferrin saturation
大体时间:Day of surgery
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Diagnosis of iron deficiency anaemia
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Day of surgery
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Serum ferritin
大体时间:Day of surgery
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Diagnosis of iron deficiency anaemia
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Day of surgery
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合作者和调查者
调查人员
- 首席研究员:Netjhardt Marcin, MBChB, FCA、University of Cape Town
- 首席研究员:Francois Roodt, MBChB, FCA、University of Cape Town
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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