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临床试验/NCT04021186
NCT04021186Unknown不适用

An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients -- Improvement in Glycemic Control to Reduce the Incidence of Hyperglycaemia and Associated Complications.

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Glycemic load (mmol)

研究概览

简要总结

Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions.

Hypothesis:

Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.

详细描述

After surgical intervention, an insulin resistance condition will occur because of the following stress response. This condition will for the majority of cases results in poor glycemic control - and there will be a risk of hyperglycaemia in the hospitalized patient. This condition affects all cells in the body and therefore has associated complications such as bigger risk at multiple infections, longer healingprocess, poorer fluid balance, etc. Hyperglycaemia is associated with a poorer outcome for the patient, which can cause an increase in hospitalization days and multiple re-admissions. It is also common for the postoperative patient to experience nausea and pain as a result of both surgery and anesthesia and immobilization. To counter this, the patient receives Dexamethasone (steroid treatment).

This experiment is based on the fact that there is still insufficient attention at this postoperative insulin resistance. In a large randomized study from 2001(Van den Berghe), insulin therapy was initiated for intensive patients. This study points out that even moderate increases in blood glucose are associated with increased morbidity and that insulin therapy is both capable of reducing mortality and morbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid.
  • >18 yrs.
  • Expected admission time of a minimum of 1 day

排除标准

  • Patients who do not understand and / or speak Danish
  • Patients who are demented
  • Patients included in primary robot surgery
  • Ear-surgical patients
  • Sinus surgery patients
  • Day surgery patients
  • Plastic surgical patients
  • Patients who are scheduled to transfer to ICU
  • Patients with Diabetes Mellitus type I
  • Patients on dialysis
  • If all preoperative blood samples and tests are not completed
  • Type 2 diabetics in insulin therapy
  • Anesthesia patients
  • Patients who have received large packages of pre-medication twice - eg. due to cancelled operation.

研究组 & 干预措施

Intervention

Experimental

Insulin treatment using standard measurements.

干预措施: Prevention of hyperglycemia (Other)

Control

No Intervention

Standard care.

结局指标

主要结局

Glycemic load (mmol)

时间窗: 1-5 days

All blood glucose levels of the participants will be measured every 30. min - all values will be used to make an area under the curve in final statistics.

次要结局

  • Number of re-Hospitalizations(Up to 3 months after the first discharge)
  • C-reactive protein (CRP) concentration(20 days)
  • C-Peptide(1-5 days)
  • Strength of Hand grip (kg)(20 days)
  • Blood glucose (mmol/l)(1-5 days - every 30. min.)
  • Temperature (degree celcius)(1-5 days)
  • Intracellular hydration (liters)(20 days)
  • Functional recovery(20 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Rikardt Andersen

Associated Professor, MD, MPA

University of Copenhagen

研究点 (2)

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