此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2018年5月8日 更新者:Bruce Biccard、University of Cape Town

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

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.

研究概览

地位

完全的

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

观察性的

注册 (实际的)

343

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Western Cape
      • Cape Town、Western Cape、南非、7599
        • Mitchells Plain Hospital
      • Cape Town、Western Cape、南非、7599
        • Somerset Hospital
      • Cape Town、Western Cape、南非、7599
        • Victoria Hospital
      • Cape Town、Western Cape、南非、7599
        • Groote Schuur Hospital
      • George、Western Cape、南非、7599
        • George Hospital
      • Paarl、Western Cape、南非、7599
        • Paarl Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study population comprises all adult non-cardiac, non-obstetric patients presenting for elective surgery over a period of one week at following sites: Groote Schuur -, Somerset -, Paarl -, Victoria -, Mitchell's Plain - and George Hospital.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • Obstetric, emergency and cardiac patients

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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
Prevalence of diagnosis of diabetes and anaemia
大体时间:Day of surgery
Proportion of patients with diagnosis of diabetes and anaemia
Day of surgery

次要结果测量

结果测量
措施说明
大体时间
HbA1C level
大体时间:Day of surgery
Assessment of diabetic control
Day of surgery
Transferrin saturation
大体时间:Day of surgery
Diagnosis of iron deficiency anaemia
Day of surgery
Serum ferritin
大体时间:Day of surgery
Diagnosis of iron deficiency anaemia
Day of surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年10月16日

初级完成 (实际的)

2017年10月20日

研究完成 (实际的)

2017年10月20日

研究注册日期

首次提交

2017年10月6日

首先提交符合 QC 标准的

2017年10月18日

首次发布 (实际的)

2017年10月23日

研究记录更新

最后更新发布 (实际的)

2018年5月14日

上次提交的符合 QC 标准的更新

2018年5月8日

最后验证

2018年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅