The Effects of Metformin on Morbidity and Mortality in Elderly Patients- a Prospective Randomized Control Trial (RCT)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Record episodes of pneumonia.
研究概览
简要总结
Elderly patients have an increased susceptibility to burns and a substantial mortality that has not significantly changed over the last three decades. Elderly burn patients not only have an augmented response to burn but also express a prolonged hypermetabolic response.Glucose metabolism with insulin resistance is a hypermetabolic response pathway that profoundly affects post-burn outcomes. The aim if this study is to determine whether metformin can improve morbidity and mortality in elderly burn patients. The investigators hypothesize that metformin will improve clinical outcomes and mortality of elderly burn patients by alleviating the complex inflammatory and hypermetabolic responses after burn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60 - 99 years of age.
- •≥5% total body surface area (TBSA) burn.
- •Admitted to burn center ≤ 120 hours post-burn injury.
- •At least one surgical intervention likely required.
- •Provide written informed consent.
排除标准
- •Death upon admission.
- •Decision not to treat due to burn injury severity.
- •Presence of anoxic brain injury that is not expected to result in complete recovery.
- •Pre-existing renal failure (eGFR is < 30 mL/min).
- •Severe liver disease (Child-Pugh C).
- •Pre-existing insulin-dependent type II diabetes.
- •Clinical contraindication to give metformin.
- •Allergy to metformin or insulin.
- •History of lactic acidosis while receiving metformin treatment.
研究组 & 干预措施
Control
干预措施: Placebos (Drug)
Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Record episodes of pneumonia.
时间窗: daily until discharge (1-4 months post admission depending on severity of injury)]
Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.
Organ function - Alanine transaminase (ALT)
时间窗: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: ALT (U/L).
Organ function - Bilirubin
时间窗: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: bilirubin (umol).
Record episodes of infection.
时间窗: daily until discharge (1-4 months post admission depending on severity of injury)]
Patients will be assessed daily for episodes of infection. The total number of episodes over the course of hospital stay will be recorded.
Organ function - Blood Urea Nitrogen (BUN)
时间窗: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: BUN (mmol).
Organ function - Creatinine
时间窗: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: creatinine (umol/L).
Record the episodes of sepsis.
时间窗: daily until discharge (1-4 months post admission depending on severity of injury)]
Patients will be assessed daily for episodes of sepsis. The total number of episodes over the course of hospital stay will be recorded.
Organ function - Alkaline phosphatase (ALP)
时间窗: twice weekly until discharge (1-4 months post admission depending on severity of injury)]
Organ function will be assessed by measuring the biomarker: ALP (U/L).
Record mortality
时间窗: Acute hospitalization up to one year post burn.
Patient mortality will be recorded during hospitalization and outpatient follow-ups.
次要结局
- Perform oral glucose tolerance test(once at discharge from hospital (1-4 months post admission depending on the severity of injury)])
- Measures of steady-state resting energy expenditure (REE)(weekly until discharge if a patient is intubated and ventilated (1-4 months post admission depending on severity of injury)])