Metabolomic Profiling of Diabetic Surgical Patients Receiving Perioperative Intravenous Fluids: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Untargeted GCMS to measure Metabolites.
研究概览
简要总结
Study will be initiated only after obtaining clearance from the institutional Ethics Committee. Patients will be screened based on the inclusion and exclusion criteria. Eligible chronic diabetic patients scheduled for elective spine surgery in neurosurgery department of KMC, Manipal will be enrolled after obtaining written informed consent. One of the investigators will be informing the patient regarding the study and the risk and benefits involved with it. Patient information sheet will be given to the patient and informed that participation is entirely voluntary. A written informed consent will be obtained from the patient and a copy of the same will be handed over to the patient. Blood will be drawn from the patient at below mentioned time points.
Blood sample collection:
Timepoint 1: Before induction of anesthesia in operation room
Timepoint 2: 10 minutes after completion of laminectomy
Timepoint 3: 60 minutes after shifting to recovery room
The blood serum samples collected at the three timepoints will be processed and stored for subsequent untargeted metabolomic analysis using GC-MS techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (age 18 years or older) 2.Diagnosed with chronic diabetes mellitus (type 1 or type 2) for at least 1 year, scheduled to undergo elective spine surgery with ASA 2 and ASA 3
- •Able to provide informed consent.
排除标准
- •Patients with presence of of active infection or sepsis
- •Emergency spine surgeries 3.Severe renal impairment
- •Severe hepatic impairment 5.Congestive heart failure 6.Immunocompromised state,Pregnant or lactating women, Inability to provide informed consent.
结局指标
主要结局
Untargeted GCMS to measure Metabolites.
时间窗: Timepoint 1: Before induction of anesthesia in operation room | Timepoint 2: 10 minutes after completion of laminectomy | Timepoint 3: 60 minutes after shifting to recovery room
次要结局
- Type and volume of fluid administered.(Hourly blood glucose level)
研究者
Dr Ravitej Bhat
Kasturba medica College, Manipal