Early Norepinephrine in Trauma Patients With Hemorrhagic Shock (ENTHeS Trial): A Randomized Open-label Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 24-hour mortality
研究概览
简要总结
The goal of this clinical trial is to learn if norepinephrine works to treat trauma patients with hemorrhagic shock. It will also learn about the safety of norepinephrine. The main questions it aims to answer are:
Does norepinephrine affect the short-term mortality (24-hour mortality)? Does norepinephrine affect the long-term mortality (30-day mortality), survival with favorable outcome, total volume of blood product and crystalloid given in 24 hours, estimated blood loss within 24 hours, resuscitation-related complications, and length of ICU and hospital stay? What medical problems do participants have when receiving norepinephrine? Researchers will compare norepinephrine to a placebo (a look-alike substance that contains no drug) to see if norepinephrine works to treat trauma patients with hemorrhagic shock.
Participants will:
Receive norepinephrine or a placebo intravenously within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.
Patients are monitored for outcomes and adverse events.
详细描述
Study Population: Adult trauma patients with hemorrhagic shock
Inclusion Criteria:
-
Adult trauma patients aged 18 to 65 years
-
Significant bleeding from traumatic events including
-
Exsanguinous external bleeding (500 ml or more), or
-
Evidence of internal bleeding (e.g., FAST positive, hemothorax, or bleeding seen on CT scan)
-
Hemorrhagic shock is defined as:
-
Hypotensive event suspected from hemorrhagic shock, characterized by
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
- None
盲法说明
The independent nurse prepares the drug (norepinephrine or placebo) according to the randomization code associated with the study ID and then sends it to the trauma bay. The appearance of both norepinephrine and placebo preparations will be identical. Both patients and physicians will remain blinded after the intervention assignment. An emergency unblinding service is available if the clinician believes that clinical management depends on knowing whether the patient received norepinephrine or placebo. Attending physicians will also be unblinded in the event of serious adverse events that require discontinuation of the study.
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
- •Adult trauma patients aged 18 to 65 years
- •Significant bleeding from traumatic events including
- •Exsanguinous external bleeding (500 ml or more), or
- •Evidence of internal bleeding (e.g., FAST positive, hemothorax, or bleeding seen on CT scan)
- •Hemorrhagic shock is defined as:
- •Hypotensive event suspected from hemorrhagic shock, characterized by
- •Systolic blood pressure less than 90 mmHg,
- •Mean arterial pressure less than 65 mmHg, or
- •A decrease in blood pressure from baseline more than 30 mmHg (as recorded in the trauma bay, resuscitation room of the emergency department at Ramathibodi Hospital, trauma unit at Siriraj Hospital, or trauma ward/ ICU) OR
- •Signs of shock, including:
- •Capillary refill time greater than 2 seconds,
- •Base excess less than -6 mEq/L,
- •Lactate level greater than 2 mmol/L)
排除标准
- •Prehospital cardiopulmonary resuscitation or cardiopulmonary resuscitation at the trauma bay.
- •Persistent shock for more than 12 hours prior to randomization.
- •Severe traumatic brain injury with Glasgow Coma Scale (GCS) score less than 9 (GCS 3-8)
- •Traumatic limb injury with acute limb ischemia
- •A history of limb ischemia, chronic heart disease, chronic lung disease, or chronic renal disease
- •Pregnant patients
- •Documented "Do Not Resuscitate" (DNR) order or who declined life-sustaining intervention before randomization
- •Allergic to norepinephrine or contraindications for its use (e.g., peripheral vascular thrombosis, mesenteric thrombosis, and fatal tachyarrhythmia)
- •Current use of ergotamine, monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants (TCAs)
- •Prior vasopressor administration before randomization.
- •Weight less than 30 kilograms (Extremely low body weight may increases the risk of weight-based dosing issues)
研究组 & 干预措施
Norepinephrine
Norepinephrine bitartrate (LEVOPHEDR, Pfizer inc.) 4 mg/4ml + 5% Dextrose in water 246 ml (total volume 250 ml, final concentration 16 mcg/ml) infuses intravenously via a central catheter or peripheral line with the rate of 10 ml/h (equivalent to 0.05 mcg/kg/min for a 50-kg patient). The drug will be initiated within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.
干预措施: Norepinephrine (Drug)
Placebo
5% Dextrose in water 250 ml infused intravenously at a rate of 10 ml/h. The drug will be initiated within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.
干预措施: Placebo (Drug)
结局指标
主要结局
24-hour mortality
时间窗: From enrollment to the end of treatment at 24 hour
The outcome will be analyzed 24 hours after the patient is enrolled.
次要结局
- 30-day mortality(From enrollment to 30 days after treatment.)
- Survival with favorable outcome at 30 days(From enrollment to 30 day after treatment.)
- The cumulative volume of blood product within 24 hours(From enrollment to the end of treatment at 24 hour.)
研究者
Visarat Palitnonkiat
Faculty of Medicine Ramathibodi Hospital
Ramathibodi Hospital