NCT02609152撤回3 期
Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock: a Multicentre, Randomized, Double-blind Trial
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Is stroke volume increased ≥ 15% as compared to baseline?
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness of the administration of a short acting beta-blocker in terms of effective increase in stroke volume (at least 15%) after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile after 12-24 hours of care.
This research seeks to demonstrate that the proportion of patients with an increase in the systolic ejection superior or equal to 15% (relative to baseline) at four hours is different between the two arms of the study: (1) an experimental arm where patients receive an esmolol infusion according to a predetermined procedure and (2) a control arm where patients receive a saline infusion according to a predetermined procedure.
详细描述
The secondary objectives are to compare the following items between the two arms of the study:
A. Central venous oxygen saturation at 4 hours (H4)
B. Changes in plasma concentration of lactates between H0 and H4
C. Changes in the tissue oxygen saturation between H0 and H4
D. Changes in echocardiographic parameters of systolic function of the left ventricle (LV) and right ventricle (RV), as well as diastolic LV function between H0 and H4
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or his/her representative was informed about the implementation of the study, its objectives, constraints and patient rights or emergency consent
- •The patient or his/her representative must haven given free and informed consent and signed the consent or emergency consent
- •The patient must be affiliated with or the recipient of a health insurance plan
- •Septic shock criteria: shock for which the suspected or proven starting point is an infection requiring vasopressors after adequate fluid resuscitation that started within the past 24 to 72 hours
- •Precharge independence criteria obtained: i.e. pulsed pressure variation <13% or variation in ejection volume <10% or variation in the cardiac index after passive lift leg <10% or central venous pressure between 8 and 12 mmHg.
- •Antibiotic treatment in progress
- •Prescription ongoing vasopressor for 24 to 72 hours.
- •Sinus rhythm
- •Heart rate > 100 beats per minute
- •Cardiac Index measured by thermodilution greater than 4.0 l / min / m^2
- •Central venous oxygen saturation > 80% without positive inotropics such as dobutamine or isoproterenol (continuously taken or measured via central venous line in superior vena cava territory) on two successive samples in 12 hours
- •Monitoring of stroke volume (invasive, semi-invasive or ultrasound)
排除标准
- •The patient is participating in another study
- •The patient has participated in another study in the last 3 months
- •The patient is in an exclusion period determined by a previous study
- •The patient is under any kind of guardianship
- •The patient is under judicial protection
- •The patient or his/her representative refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contraindication for a treatment used in this study
- •Cardiac index < 4.0 l / min / m^2
- •Need to introduce a positive inotropic agent (as determined by the physician in charge of the patient)
- •Contraindications to the use of esmolol: Severe sinus bradycardia (less than 50 beats per minute); Sinus pathologies, severe disorders of atrioventricular conduction (without pacemaker), atrioventricular blocks of second and third degree; Cardiogenic shock; Severe hypotension; Decompensated heart failure; Untreated pheochromocytoma; Pulmonary hypertension; Acute asthma attack; chronic obstructive pulmonary disease; peripheral arterial disease; Metabolic acidosis; Known hypersensitivity to esmolol.
- •Patient with kidney failure (RIFLE Stage L)
- •Chronic treatment with beta blocker
- •Patient with ultrasound assessment of left ventricular ejection fraction < 40%
研究组 & 干预措施
Continuous perfusion of esmolol
Experimental
Intervention: Drug: Continuous perfusion of esmolol
干预措施: Continuous perfusion of esmolol (Drug)
Continuous perfusion of saline
Placebo Comparator
Intervention: Continuous perfusion of saline
干预措施: Continuous perfusion of saline (Drug)
结局指标
主要结局
Is stroke volume increased ≥ 15% as compared to baseline?
时间窗: 4 hours
次要结局
- Percentage variation o, inflammatory cytokines (interleukin 1) with respect to baseline values(4 hours)
- Absolute values of the E' wave(4 hours)
- Absolute value of the ratio E/A on pulsed Doppler at the mitral annulus(4 hours)
- Absolute Value of the ratio E/E ' one tissue Doppler at the mitral annulus(4 hours)
- Percentage variation o, inflammatory cytokines (interleukin 10) with respect to baseline values(4 hours)
- The time spent with a central venous oxygen saturation between 70% and 80% (minutes)(4 hours)
- Evolution of blood lactate between H0 and H4(4 hours)
- Changes in tissue oxygen saturation compared to baseline(4 hours)
- Ejection fraction of the left ventricle drops below 40% between H0 and H4? yes/no(4 hours)
- the change (in %) of the systolic S wave on the tissue doppler at the mitral annulus relative to baseline(4 hours)
- right ventricle / left ventricle diameter ratio(4 hours)
- Use of positive ionotropic agents? yes/no(4 hours)
- Percentage change in the expression of the human leukocyte antigen-DR gene with respect to baseline(4 hours)
- Number of days free of organ failure(Dmax +1 (Dmax has an expected maximum of 28 days))
- Mortality(Dmax +1 (Dmax has an expected maximum of 28 days))
- Change (%) in the sub aortic time-speed integral relative to baseline(4 hours)
- Absolute values of the E wave(4 hours)
- Right ventricular systolic function(4 hours)
- Vascular filling volume (ml)(4 hours)
- Diuresis (ml/kg/h)(collected between hours 0 and 4)
- Required duration of vasopressors (min)(4 hours)
- Change in creatinine relative to baseline (µmol/L)(4 hours)
- Percentage variation o, inflammatory cytokines (tissue necrosis factor) with respect to baseline values(4 hours)
- Length of stay in the intensive care unit (days)(Expected maximum of 28 days)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
4 期
Effect of Esmolol on Perioperative Stress ReactionEsmololStress ReactionAirway ObstructionOverproduction CatecholamineNCT05694585Xiumei Song46
招募中
不适用
The Impact of Esmolol Administration on Postoperative RecoveryPain, AcutePain, PostoperativePain, Chronic Post-SurgicalEsmololInguinal Hernia RepairAnalgesiaNociceptive PainNCT05567822Aretaieion University Hospital70
终止
4 期
Esmolol Infusion During Laminectomy: Effect on Quality of RecoveryLaminectomyNCT01179113Cedars-Sinai Medical Center33
招募中
4 期
Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.Opioid Use, UnspecifiedAnesthesiaNociceptive PainNCT06291363Ciusss de L'Est de l'Île de Montréal64
终止
3 期
Esmolol for Treatment of Perioperative TachycardiaHigh-risk, Non-cardiovascular SurgeriesNCT01208402Duke University76