ISRCTN36307479已完成未知
A multicentre, randomised controlled trial of the clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock
Intensive Care National Audit and Research Centre (ICNARC) (UK)0 个研究点目标入组 1,260 人开始时间: 2009年11月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,260
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
- •1. Greater than or equal to 18 years of age, either sex
- •2. Known or presumed infection
- •3. Two or more systemic inflammatory response syndrome (SIRS) criteria:
- •3.1. Core temperature less than or equal to 36°C or greater than or equal to 38°C
- •3.2. Heart rate greater than or equal to 90 beats/min
- •3.3. Respiratory rate greater than or equal to 20 breaths/min (or hyperventilation indicated by partial pressure of carbon dioxide in arterial blood [PaCO2] 4.3 kPa or mechanical ventilation for an acute process)
- •3.4. White blood cell count less than or equal to 4 x 10^9 l or greater than or equal to 12 x 10^9 l (or the presence of greater than 10% immature neutrophils bands)
- •4. Refractory hypotension or hypoperfusion:
- •4.1. Hypotension is confirmed by the presence of systolic blood pressure less than 90 mmHg despite an intravenous (IV) fluid challenge of at least 20 ml/kg within 30 minutes of Emergency Department (ED) arrival (including IV fluids administered by pre-hospital/Emergency Medical Services [EMS] personnel)
- •4.2. Hypoperfusion is confirmed by a blood lactate concentration greater than or equal to 4 mmol/L)
- •5. First dose of IV antimicrobial therapy commenced prior to randomisation
排除标准
- •Current exclusion criteria as of 04/01/2013:
- •1. Age less than 18 years
- •2. Known pregnancy
- •3. Primary diagnosis of:
- •3.1. an acute cerebral vascular event
- •3.2. acute coronary syndrome
- •3.3. acute pulmonary oedema
- •3.4. status asthmaticus
- •3.5. major cardiac arrhythmia (as part of primary diagnosis)
- •3.6. seizure
- •3.7. drug overdose
- •3.8. injury from burn or trauma
- •4. Haemodynamic instability due to active gastrointestinal haemorrhage
- •5. Requirement for immediate surgery
- •6. Known history of AIDS
- •7. Do-Not-Attempt-Resuscitation (DNAR) status
- •8. Advanced directives restricting implementation of the resuscitation protocol
- •9. Contraindication to central venous catheterization
- •10. Contraindication to blood transfusion
- •11. Attending clinician deems aggressive resuscitation unsuitable
- •12. Transferred from another in-hospital setting
- •13. Not able to commence resuscitation protocol within one hour of randomisation or complete six hours of protocol treatment from commencement
- •Previous exclusion criteria until 04/01/2013:
- •1. Aged less than 18 years
- •2. Known pregnancy
- •3. Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary oedema, status asthmaticus, major cardiac arrhythmia (as part of primary diagnosis), seizure, drug overdose, injury from burn or trauma
- •4. Haemodynamic instability due to active gastrointestinal (GI) haemorrhage
- •5. Immunosuppressive agents including chemotherapy for uncured cancer, immunosuppression for organ transplantation or from systematic disease
- •6. Requirement for immediate surgery
- •7. Do not resuscitate status
- •8. Advanced directives restricting implementation of the protocol
- •9. Contraindications to central venous catheterisation
- •10. Contradiction to blood transfusion (i.e. Jehovah's Witness)
- •11. Attending physician deems aggressive care unsuitable
- •12. Participation in another interventional study
- •13. Transferred from another in-hospital setting
- •14. Not able to start within 1 hour of randomisation or finish within 6 hours
研究者
相似试验
招募中
3 期
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled TrialACTRN12608000053325Australian and New Zealand Intensive Care Research Centre1,600
进行中（未招募）
3 期
Trial of sertraline to prevent post-traumatic brain injury depressioDepressive disorder after traumatic brain injuryMental and Behavioural DisordersISRCTN17518945King's College Hospital514
已完成
不适用
Internet-based relapse prevention for in-patients with anorexia nervosaSevere anorexia nervosa (AN)Mental and Behavioural DisordersEating disordersISRCTN18274621South London and Maudsley NHS Foundation Trust (UK)98
已完成
3 期
A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis.RS viral bronchiolitisJPRN-UMIN000001700Tokyo Metropolitan Children's medical center Hospital120
已完成
不适用
A multi-center, randomized, controlled trial on the efficacy and safety of metal stents for biliary drainage prior to pancreatic cancer surgerypancreatic cancerJPRN-UMIN000032076Juntendo University200