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临床试验/NCT03867565
NCT03867565尚未招募不适用

The Role of Nutrition After Minor Burns

Uppsala University0 个研究点目标入组 84 人开始时间: 2019年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
主要终点
Change in nitrogen loss from trauma to 12 months after minor burns

研究概览

简要总结

Nutrition therapy has an important role in burn care to optimize wound healing, prevent muscle wasting, improve immune function and decrease risk of infection and sepsis. The body of literature concerning major burns´nutritional requirements has increased over the last decades, however the role of nutrition after minor burns (TBSA < 20 %) is virtually unexplored and in need of further investigation. Hence, this study explores if adequate nutritional status after minor burn results in better outcome.

详细描述

Phase 1 Aim To study energy- and protein requirements after minor burns in adults (TBSA < 20 %).

Research questions Do energy- and protein requirements increase after minor burns? Do energy- and protein requirements proportionally increase with the severity of injury; depth and extent after minor burns? Study design/methods Sample size: 84 patients and 84 healthy control subjects (matched by age, gender and BMI).

Method: All consecutive burns, admitted for treatment at Uppsala Burn Center, fulfilling inclusion and exclusion criteria are asked to take part in this phase. Oral and written informed consent is collected. Patients background data (severity of burn injury, including depth and extent, and the treatment thereof, concomitant diseases and medications, age, weight, height, gender, socioeconomic status, alcohol- and tobacco use, physical activity level using activity meters, as well as data from questionnaire obtained from routine standard of care at Burn Center about sleep, quality of life, pain and depression) will be collected. Measure (indirect calorimetry) and calculate energy requirement (Mifflin St Jeor equation x Injury Factor x physical activity level) within 2 weeks after injury and 1, 3, 6, and 12 months after injury. Measure nitrogen balance (nitrogen balance = nitrogen intake - nitrogen loss). Collecting data from blood sample to measure inflammatory response (albumin, transferrin, CRP), if the body can use more protein (urea) and measurement of normal kidney function (cystatin-C).Collecting data from 24-h-urine collection, urea for calculation of nitrogen balance to distinguish between protein intake compared and muscle breakdown. Data for calculation of protein intake from nutritional assessment and 4-day food record. Results are compared with 84 healthy control subjects measured with indirect calorimetry, blood sample, urine collection, and intake measurement.

Phase 2 Aim To describe nutritional status in adult patients after minor burns. Nutritional status is defined as to what degree physiological nutrient needs are met (energy- and protein intake compared to measurements and calculations, carbohydrate-, fat-, vitamin-, and mineral intake compared to estimated average requirements. Weight and muscle mass compared to normal body composition and its development over time).

Research questions Do minor burns affect nutritional status? Does nutritional status differ related to injury severity? Sample size: 84 patients included in Phase 1 are asked to take part in this study.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Minor burn, TBSA < 20 %
  • Age ≥ 18 years old
  • Understands Swedish or English verbally and in writing
  • Mentally adequate
  • Oral and written informed consent.

排除标准

  • Patients deemed not to be able to complete study protocol.
  • TBSA < 2 %.

研究组 & 干预措施

No nutritional diagnosis

No Intervention

Patients without nutritional diagnosis get SOC

Nutritional diagnosis

Experimental

Patients with nutritional diagnosis get nutritional intervention by dietitian.

干预措施: Nutritional intervention (Other)

结局指标

主要结局

Change in nitrogen loss from trauma to 12 months after minor burns

时间窗: Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury.

Nitrogen loss is calculated from 24-h-urine collection (urea).

Weight development from trauma to 12 months after minor burns

时间窗: Every week after trauma until no more need for dressing changes via health care facility and also within 2 weeks after injury, 1, 3, 6, 12 months after injury.

Weight will be measured every week after trauma until no more need for dressing changes via health care facility. For all patients´ weight will also be measured within 2 weeks after injury, 1, 3, 6, 12 months after injury. During the patients´ stay/visits at the burn center this is done at the hospital. Thereafter weight will be measured at home/external health facility.

Change in nitrogen intake from trauma to 12 months after minor burns

时间窗: Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury.

Nitrogen intake is measured and calculated from a 4-day food record

Wound healing from trauma to 12 months after minor burns

时间窗: Every week after trauma until no more need for dressing changes via health care facility and also within 2 weeks after injury, 1, 3, 6, 12 months after injury

As surrogate parameter for number of days to wound healing the number of days from burn to no more need of dressing changes via health care facility will be measured

Change in energy balance from trauma to 12 months after minor burns

时间窗: within 2 weeks after injury, 1, 3, 6, 12 month after injury

Resting energy expenditure (REE) measured by indirect calorimetry to study energy requirements. REE are added with measurement of physical activity level (PAL) from 4-day activity measurement and compared to energy intake (that are collected from 4-day food record) to analyze energy balance.

Frequency of infection from trauma to 12 months after minor burns

时间窗: within 2 weeks after injury, 1, 3, 6, 12 month after injury

As surrogate parameter for frequency of infections the number, sort, dose, and length of antibiotic treatment(s) during the period

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

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