ISRCTN11597444已完成不适用
Vasopressin in pediatric vasodilatory shock: a multicentre, two armed, placebo controlled randomised parallel trial
Children?s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)0 个研究点目标入组 69 人开始时间: 2003年9月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 20/12/2007:
- •1. Age: 1 month to 18 years, either sex
- •2. Vasodilatory shock: patient must be within 24 hours of fulfilling criteria 2.1. and 2.2.:
- •2.1. Fluid and catecholamine refractory shock: patient must fulfill criteria 2.1.1. and 2.1.2.:
- •2.1.1. Fluid administration (greater than or equal to 40 ml/kg crystalloid/colloid)
- •2.1.2. Minimum vasoactive infusion requirement for eligibility - either one of:
- •2.1.2.1. Dopamine greater than or equal to 10 µg/kg/min
- •2.1.2.2. Any dose of epinephrine, norepinephrine or phenylephrine
- •2.2. Clinical evidence of Vasodilation/Warm shock. These physical signs may be present at any time, including prior the institution of the vasoactive infusions listed in point 2.1.2.: patient must fulfill criteria 2.2.1., plus any two of the three criteria 2.2.2., 2.2.3. or 2.2.4. for eligibility:
- •2.2.1. Low diastolic blood pressure (BP) (as defined by diastolic BP less than half systolic BP value)
- •2.2.2. Tachycardia (as defined by heart rate [HR] greater than 2 SD for age)
- •2.2.3. Warm extremities
- •2.2.4. Flash capillary refill
- •3. Arterial line
- •4. Central venous line (a pulmonary artery catheter is optional)
- •5. Commitment of intensive care unit (ICU) team to full aggressive support
- •6. Informed consent: from parent or appropriate substitute decision-maker
- •Previous inclusion criteria:
- •1. Pediatric patients with vasodilatory shock, despite volume resuscitation and catecholamine pressor administration
- •2. Children greater than 1 month and less than 18 years of age, either sex
排除标准
- •Added as of 20/12/2007:
- •1. Terminal illness (death anticipated in 24 hours, or withholding therapy considered)
- •2. Pregnancy
- •3. Known history of hypersensitivity to exogenous vasopressin
- •4. Cardiac Index less than or equal to 2.5 L/min/m^2 after fluid resuscitation (this is in the event that a formal cardiac index measurement has been performed, e.g. by Echo or Swan Ganz catheter)
- •5. Severe hyponatremia (serum sodium less than 125 mM) not responding to water restriction
- •6. Known history of vasospastic diathesis, e.g. Raynaud's phenomenon
- •7. Concurrent use of intravenous vasodilator agents: i.e. sodium nitroprusside, within 12 hours of phenoxybenzamine use
- •8. Patient who has received intravenous vasopressin or vasopressin analogue within 24 hours of eligibility
- •9. Diagnosis of syndrome of inappropriate antidiuretic hormone secretion (SIADH) or Diabetes Insipidus
- •10. Inability to obtain informed consent
- •11. Previous enrollment in the VIP study
研究者
相似试验
尚未招募
不适用
Effect of vasopressin in sick babies with low blood pressureCTRI/2022/12/048258Dr Anup Thakur
已完成
不适用
Vasopressin in Paediatric cardiac SurgeryCTRI/2020/10/028316Army Hospital Research and Referral88
已完成
不适用
Vasopressin and Corticosteroids in septic ShockTopic: Generic Health Relevance and Cross Cutting ThemesSubtopic: Generic Health Relevance (all Subtopics)Disease: Critical CareInfections and InfestationsSeptic shockISRCTN66727957Imperial College London (UK)60
进行中（未招募）
不适用
Vasopressin and Corticosteroids in Septic Shock - Vasopressin and Corticosteroids in Septic Shock. Version 1.0Septic shock - low blood pressure due to infectionEUCTR2009-017636-41-GBImperial College
已完成
1 期
The haemodynamic effects of Vasopressin in early hyperdynamic septic shockACTRN12606000087550Prince of Wales Hospital25