Optimal Vasopressor Titration Pilot Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Vasopressors
- 疾病 / 适应症
- Hypotension
- 发起方
- Francois Lamontagne
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- MAP While on Vasopressors
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.
详细描述
Patients who are admitted to the intensive care unit (ICU) commonly suffer from shock, a condition that causes life-threatening low blood pressure. Low blood pressure makes it difficult for the body to deliver blood to all of its organs. The standard treatment doctors in the ICU use for their patients is to give medications that help increase blood pressure. These medications are called vasopressors. There can be side effects related to using vasopressors. The purpose of this research study is to determine if it is better to give vasopressors to patients to maintain a higher blood pressure target versus a lower blood pressure target. This study is important because the information we find out will help us know how best to administer vasopressors in patients with shock in the ICU.
研究者
Francois Lamontagne
Assistant Professor, Universite de Sherbrooke
Clinical Evaluation Research Unit at Kingston General Hospital
入排标准
入选标准
- •Who are receiving vasopressors for distributive shock
- •Who are older than 16 years of age at the time of eligibility.
- •Who are under the direct care of the ICU team regardless of location.
- •Who have received a minimum of 30 mL/kg of intravenous fluids (2100 mL for a 70 kg patient) before enrolment OR the most responsible physician has good reasons to believe that more fluid resuscitation is no longer required and could be harmful.
- •Who the treating physician believes will need vasopressors for at least 6 hours once enrolled.
排除标准
- •Have received vasopressors for more than 24 consecutive hours; if vasopressors are discontinued for \>= 2 hours then restarting vasopressors will constitute a distinct vasopressor episode and the clock will be reset.
- •Are judged by the treating physician to be in obvious cardiogenic shock after an acute myocardial infarction (based on new ST segment elevations on ECG or obvious echocardiographic findings).
- •Have obvious haemorrhagic shock as a consequence of a clearly identified source of blood loss.
- •Require vasopressors after cardiac surgery as a result of cardiopulmonary bypass-induced hypotension.
- •Who have a specific indication for catecholamine therapy other than shock (i.e. angioedema or intracranial hypertension).
- •If the attending team has agreed to withhold or withdraw life sustaining care.
- •Concurrent enrollment in interventional trials that do not meet guidelines (see ccctg.ca) for co-enrollment (co-enrollment is permissible if there is no potential interaction between the protocols; this will be addressed case by case).
- •Prior randomization in this study.
研究组 & 干预措施
Liberal Approach
In the liberal approach group, we will titrate vasopressors to maintain mean arterial pressures between 75 and 80 mmHg.
干预措施: Vasopressors
Restrictive Approach
We will titrate vasopressors to maintain mean arterial pressures between 60 and 65 mmHg.
干预措施: Vasopressors
结局指标
主要结局
MAP While on Vasopressors
时间窗: While on vasopressors from randomization until 28 days
The primary feasibility outcome will be the difference in the means of mean arterial pressures (MAP) while on vasopressors and we define acceptable adherence (the threshold for feasibility) by a difference of at least 5 mmHg while on vasopressors (rejecting the null hypothesis of a difference of less than 5 mmHg - see proposed sample size).