In Vivo Cellular and Physiological Response to Severe Burns Injuries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Monitor the change in resting metabolic rate over period of time after severe burns injury.
研究概览
简要总结
Severe burn patients are some of the most challenging critically ill patients with an extreme and continuous state of physiological stress. Patients tends to stay for a long period of time in intensive care unit to treat burns as well as dealing with complications that arises from the initial burns injury. Severe burns patients are notoriously known to loose weight. The word 'catabolism' is used medically. This theory of catabolism after a trauma was hypothesised in 1942 by Professor Curthberston and based on animal models. Since this date, despite medical technological advancement, there has been no research that confirms Professor Curthberston's theory. Investigators still do not know the exact mechanism by which the body changes from conserving energy to becoming catabolic. Furthermore, it remains unclear whether this change in catabolism is necessary to heal from burns injury.
This theoretical catabolism in burns patients is currently treated with nutritional supplement, use of medications including beta-blockers (suppresses heart rate and decreases blood pressure) and oxandrolone (formula which is similar to testosterone to build up muscles).
There are evidences to suggest that increase in weight loss worsens the outcome in burns injury. Both overfeeding or underfeeding patients can be detrimental. In this research, the exact changes in metabolic rate will be measured in the first 72 hours of the study using a calorimetry machine. In addition to the metabolic rate, the response to the heart, liver, kidneys and hormonal levels will be measured. By looking into these dynamic changes the investigator will be able to elucidate whether there is a real increase in metabolic rate. If there is, the investigator would also be able to tell the response of different organs and whether there are any hormones that could be responsible to inflicting the metabolic changes.
详细描述
- Purpose of the study The purpose of this study is to gain a better understanding of the acute physiological and metabolic changes in severe burns injury. Unless clinicians understand the physiological effect in burns patients, clinicians are unable to develop new therapeutic interventions to halt the hyper metabolic changes in burns patient. This research will be looking into the acute resting basal metabolic changes in severe adult burns patients by using Quark RMR (indirect calorimetry). This equipment will allow the investigator to detect the metabolic switch in severe burns patients.
In addition to the metabolic changes, 'Estimated cardiac output monitor' will be placed in conjunction with calculating the Fick principle. Heart rate and pulse oximeter will be monitored continuously. These adjuncts will allow the investigator to conclude whether hyper-metabolism is associated with hyper dynamic cardiovascular response to burns.
Splanchnic circulation will be monitored using the LiMON indocyanine green test and intermittent intra-abdominal pressure will be monitored to assess whether there is a link between the metabolic rate and splanchnic circulation. 2. Objectives
- Primary Objective:
Identifying the 'Ebb' phase and 'Flow' phase in acute burns injury 2. Secondary Objectives:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 16 years or over
- •Informed, written consent from patient. If the participant is unable to give consent then assent will be considered.
- •Burns more than 15%
- •Acute presentation
排除标准
- •Any concern from the clinical team that the application or ongoing presence of the monitoring device would interfere with optimal patient management.
- •Allergy to adhesives used for monitor leads and belts.
- •Participants below 16 years old
- •Burns less than 5%
- •Conditions that gives an inaccurate calorimetry results
- •Participants needing oxygen concentration more than 60%
- •Participants who have broncho-alveolar fistula
- •Participants with chest drains
- •Airway leak within the ventilated systems
结局指标
主要结局
Monitor the change in resting metabolic rate over period of time after severe burns injury.
时间窗: Continuous monitoring over 72 hours
The resting metabolic rate will be measured using Quark Indirect Calorimetry Machine from Cosmed, Italy. The rested metabolic rate will be measured in kilo calories.
次要结局
- Monitor the cardiac output using Fick principle in severe burns(The cardiac output will be measured using the fick principle.The cardiac output will be measured at 12th, 24th, 36th, 48th, 60th 72nd hour from the point of the injury. 10 patients will be recruited over a year.)
- Monitor the splanchnic circulation by measuring the indocyanine green clearance rate.(The splanchnic circulation will be measured at 12th, 24th, 36th, 48th, 60th 72nd hour from the point of the injury. 10 patients will be recruited over a year.)
研究者
Marcela P. Vizcaychipi
Consultant in Anaesthesia and Intensive Care Medicine Honorary Senior Clinical Lecturer Divisional Research Lead for Planned Care Surgery and Clinical Support
Chelsea and Westminster NHS Foundation Trust