跳至主要内容
临床试验/NCT01860001
NCT01860001Unknown不适用

Incidence of Postoperative Ketosis and Metabolic Acidosis

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery

研究概览

简要总结

The aim of this study is to define the incidence and nature of acidosis after major surgery using Figge's equations to directly measure acidosis. This study will also aim to compare the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.

详细描述

Metabolic acidosis is a frequent occurrence following major surgery. Monitoring acid base disturbances and in particular diagnosing the aetiology of the acidosis are important parts of assessing a patient's cardiovascular status following surgery. The presence of a metabolic acidosis is frequently attributed to anaerobic metabolism leading to the generation of lactic acid due to hypovolaemia and poor tissue perfusion. This commonly results in clinicians treating postoperative patients with a metabolic acidosis by administering intravenous fluids containing 0.9% saline or Hartmann's solution (compound sodium lactate). If the cause of the metabolic acidosis is not hypovolaemia, treatment with intravenous fluids may actually exacerbate the acidosis by causing hyperchloraemia. An often overlooked cause of metabolic acidosis after surgery is starvation leading to ketoacidosis. All patients are starved for a minimum of six hours prior to general anaesthesia due to the potential risk of aspiration of gastric contents into the bronchial tree. Many patients are in fact fasted for much longer periods than this. There is, however, little data describing the incidence of ketoacidosis following surgery. In addition, there may be other causes of acidosis after surgery which often overlooked but can be determined using equations and mathematical models. The aim of this study is to define the incidence and nature of acidosis after major cancer surgery using using equations to directly determine acids. This study will also aim to compare the ability of commonly used indirect measures (base deficit, anion gap, corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients who have undergone major cancer surgery
  • Patients who have an arterial line in place
  • Patients who have a urinary catheter in place
  • Patients who will be admitted to intensive care following surgery
  • Adults >18 years
  • Adults who are capable of reading and understanding English

排除标准

  • Patient refusal
  • Patients without an arterial line or urinary catheter in place
  • Patients receiving glucose / sliding scale insulin for management of diabetes mellitus

结局指标

主要结局

Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery

时间窗: 31/08/13

次要结局

  • Incidence of metabolic acidosis, defined by base deficit . 2 mEq/L (Henderson-Hasselback) within one hour of completion of surgery.(31/08/13)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验