Leptin: a Therapeutic Option for Treating Catabolic States and Malnutrition in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To assess in the intensive care setting leptin levels and their relationship to inflammatory cytokines during the course of catabolic illnesses and following recovery.
研究概览
简要总结
Leptin is a hormone that plays a central role in food intake and energy balance. It is secreted by fat cells, released into the circulation and transported into the central nervous system (brain), where it regulates energy balance and food intake. The overall effects of leptin appear to reduce food intake when the body is calorically satisfied, and to alter metabolic rate A decrease in the amount of body fat, which occurs after fasting, reduces the level of leptin, thereby stimulating food intake. Systemic Inflammation is a condition in which body tissues respond to stress. It may be associated with severe infection or other stimuli such as trauma, and may lead to organ failure and death. It has been shown, that Leptin may be a "survival protein", where higher levels are associated with lower mortality. The investigators set out to quantify the levels of Leptin in critically ill patients in association with other markers of inflammation and mortality.
详细描述
Patients admitted to the Medical Intensive Care Unit who comply with criteria for SIRS (Systemic inflammatory response syndrome) will be enrolled into the study.
SIRS can be diagnosed when two or more of the following are present:
- Heart rate > 90 beats per minute
- Body temperature < 36 or > 38°C
- Hyperventilation (high respiratory rate) > 20 breaths per minute or, on blood gas, a PaCO2 < 32 mm Hg or mechanically ventilated
- White blood cell count < 4000 cells/mm3 or > 12000 cells/mm3 (< 4 x 109 or > 12 x 109 cells/L), or the presence of greater than 10% immature neutrophils.
Clinical parameters will be collected including: demographics, diagnosis, past medical history, past and present medications, fluids and nutrition administered, oxygenation and ventilation parameters, hemodynamic status and renal function and/or replacement therapy. Severity of illness using APACHE II score, major events during unit stay such as procedures, length of inotropic support, complications. Length of unit and hospital stay, length of ventilation, unit and hospital outcome.
Baseline leptin levels (within 8 hours of admission) will be obtained. Subsequent levels of leptin will be measured every 2 days or until discharge from the unit or death.
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
- 否
入选标准
- •All patients with Systemic Inflammatory Response Syndrome (SIRS).
- •SIRS can be diagnosed when two or more of the following are present:
- •Heart rate > 90 beats per minute
- •Body temperature < 36 or > 38°C
- •Hyperventilation (high respiratory rate) > 20 breaths per minute or, on blood gas, a PaCO2 < 32 mm Hg or mechanically ventilated
- •White blood cell count < 4000 cells/mm3 or > 12000 cells/mm3 (< 4 x 109 or > 12 x 109 cells/L), or the presence of greater than 10% immature neutrophils.
排除标准
- •Patients under 18, pregnant patients, patients who refuse to participate
结局指标
主要结局
To assess in the intensive care setting leptin levels and their relationship to inflammatory cytokines during the course of catabolic illnesses and following recovery.
时间窗: 14 days, discharge from ICU or death
次要结局
- To measure indices of metabolism, catabolism and ICU outcome and their associations with leptin response.(14 days, ICU discharge or death)