Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- APACHE II on Day 7
研究概览
简要总结
This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.
详细描述
This is a prospective, randomized, single-blind, parallel-controlled clinical trial. The global objective is to compare the organ protective effects of the sedation and analgesia regimen (midazolam, fentanyl) with the modified sedation and analgesia regimen (midazolam, fentanyl, cetirizine) in patients with severe burns (≥30% TBSA). Participants will receive the intervention from admission to 72 hours post-burn. Researchers will take the APACHE II scores on days 7 after admission as the main outcomes. Researchers will also take other supplementary examination results into account, including liver enzyme, myocardial enzyme, renal function, haemodynamic index, coagulation function, and pulmonary interstitial edema.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form
- •Commitment to comply with the procedures and cooperation during the course
- •TBSA >30% and admitted within the first day after burns
- •No severe compound injuries
排除标准
- •History of allergy to drugs in the trial
- •Postoperative complications that would interfere with the observation
- •Mental illness and severe heart disease, hypertension
- •Serious genetic diseases
- •Incomplete clinical information (unclear diagnosis, incomplete medical history, incomplete medication records, etc.)
- •Pregnancy/lactation
- •Malignant tumors
- •Organ insufficiency due to previous chronic diseases such as hypertension, diabetes mellitus or non-burning factors
- •Serious adverse reactions
- •Self-requested withdrawal
研究组 & 干预措施
The Modified Sedation and Analgesia Regimen Group
midazolam, fentanyl, cetirizine
干预措施: Cetirizine (Drug)
The Modified Sedation and Analgesia Regimen Group
midazolam, fentanyl, cetirizine
干预措施: Midazolam and Fentanyl (Drug)
The Sedation and Analgesia Regimen Group
midazolam, fentanyl
干预措施: Midazolam and Fentanyl (Drug)
结局指标
主要结局
APACHE II on Day 7
时间窗: Day 7
Observation of APACHE II scores of patients in each group 7 days after admission. The APACHE II (Acute Physiology And Chronic Health Evaluation II) is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death.
次要结局
- Stroke Volume(Day 7)
- Urinary Output(Day 7)
- Blood L-lactate(Day 7)
- Base Excess (BE)(Day 7)
- Stroke Volume Variation(Day 7)
- Global End-Diastolic Volume(Day 7)
- Central Venous Pressure(Day 7)
- Cardiac Function Index(Day 7)
- Pulmonary interstitial edema(Day 7)
- SOFA Score(Day 7)
- Body Temperature(Day 7)
- Heart Rate(Day 7)
- Respiratory Rate(Day 7)
- Leukocyte Count(Day 7)
- Blood CRP(Day 7)
- Blood Calcitoninogen(Day 7)
- Mechanical Ventilation Duration(Day 28)
- Mortality(Day 28)
- Sepsis Rate(Day 28)
- Oxygen Saturation(Day 7)