Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- change of CRP
研究概览
简要总结
Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine bark extract.
Objective: The main objective of present study is surveying the effect of French maritime pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the first human study in the world.
Method: this is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for assessment of clinical status of patients and Nutric questionnaires for assessment of nutritional status filled out at the base line, 5th day and the end of study. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked by phone within 28 days of the start of the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th day of intervention are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.
详细描述
Randomization:
investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list of unique patient identifiers is generated by the study statistician using a computer-generated random block size. The classification is based on age (18 to 40 and 40 to 65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using quadruple blocks.
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)
盲法说明
On enrolment, study nutritionist or clinicians take a consecutive sealed opaque envelope containing the unique patient identifier but not the study group, to which they remain masked. A paired set of sealed envelopes are kept in a locked cabinet in the study laboratory, label with the unique patient identifier and containing the study group allocation. These are opened by the nutritionist. Investigators, all study staff hospital attending clinical teams, and patients were masked to the study group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission in ICU due to TBI2
- •18 year ≤ age ≤ 65 year
- •GCS score ˃ 8
- •Stable hemodynamic and metabolic status in the first 24 to 48 hours
- •Having enteral nutritional support
- •Fill out the informed consent form by the patient or first-degree relatives of the patient
排除标准
- •Pregnancy and lactation
- •Morbid obesity: BMI ≥ 40
- •Failure to start enteral nutrition in the first 24-48 hours
- •Suffering from autoimmune disorders and HIV/Aids
- •Suffering or having History of cancer and any liver failure
- •Receiving positive inotropic medications including Dopamine, Dobutamine and Epinephrine
- •Severe and active bleeding
- •Suffering from Sepsis
- •Having history of known food allergies
结局指标
主要结局
change of CRP
时间窗: 5 and 10 days
Inflammatory marker
change of Malondialdehyde
时间窗: 5 and 10 days
Oxidative stress marker
change of weight
时间窗: 5 and 10 days
measurement is done via portable scale
change of Body mass index
时间窗: 5 and 10 days
it is calculated by Equation
change of IL-1β
时间窗: 5 and 10 days
Inflammatory marker
change of IL-6
时间窗: 5 and 10 days
Inflammatory markers
change of body fat percentage
时间窗: 5 and 10 days
measurement is done via Bio impedance device "Inbody"
change of acute physiologic and chronic health evaluation II score
时间窗: 5 and 10 days
The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States. Interpretation: Score: 0-4: Death Rate (%):4, Score: 5-9:Death Rate (%):8, Score: 10-14:Death Rate (%):15, Score: 15-19:Death Rate (%):25, Score: 20-24:Death Rate (%):40, Score: 25-29:Death Rate (%):55, Score: 30-34:Death Rate (%):75. Score: ˃ 34 :Death Rate (%):85.
change of total anti- oxidant capacity
时间窗: 5 and 10 days
anti-oxidative stress marker
change of sequential organ failure assessment score
时间窗: 1, 3, 5, 7, 9, 10 days
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The SOFA was designed to focus on organ dysfunction and morbidity, with less of an emphasis on mortality prediction. Interpretation: Score: 0-6: Death Rate (%):\< 10%, Score: 7-9:Death Rate (%):15 - 20%, Score: 10-12:Death Rate (%):40 - 50%, Score: 13-14:Death Rate (%):50 - 60%, Score: 15:Death Rate (%):\> 80%, Score: 15-24:Death Rate (%):\> 90%.
change of Nutric score
时间窗: 5 and 10 days
The NUTRIC score (Nutrition assessment in critically ill) is a rapid assessment of nutritional state based on illness severity, age and co-morbidities. Sum of points: 6-10: CATEGORY: High Score. Sum of points: 0-5: CATEGORY: LOW Score High score associated with worse clinical outcomes (mortality, ventilation).These patients are the most likely to benefit from the aggressive nutrition therapy. LOW Score: These patients have a low malnutrition risk
次要结局
- 28-day mortality(28 days)
研究者
Mahsa Malekahmadi
principal investigator
Mashhad University of Medical Sciences