SQUEEZE Trial: A Trial to Determine Whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid Sparing Strategy vs. Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 8
- 主要终点
- Difference in time to shock reversal
研究概览
简要总结
The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.
详细描述
Please see published pilot trial protocol for more information about the SQUEEZE Trial and rationale for this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 29 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for 1 and 3 must be answered YES to be eligible for study.
- •Age 29 days to less than 18 years of age
- •Patient has Persistent Signs of Shock including one or more of the following:
- •Vasoactive Medication Dependence
- •Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age)
- •Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output)
- •Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause)
- •Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing 50 kg or more.
- •Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c.
排除标准
- •Patient admitted to the Neonatal Intensive Care Unit (NICU)
- •Patient requiring resuscitation in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU)
- •Full active resuscitative treatment not within the goals of care
- •Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock)
- •Previous enrolment in this trial, where known by the research team
研究组 & 干预措施
Usual Care Resuscitation Strategy
Decisions regarding the IV/IO administration of isotonic fluid boluses and/or the initiation and escalation of vasoactive medication infusions are left to the discretion of the treating physician and medical team. We ask that vasoactive medications not be initiated until at least 60 mL/kg (3 litres for children ≥ 50 kg) of isotonic fluid bolus therapy has been administered. The treating physician and medical team are advised to follow ACCM guidelines for the resuscitation of neonatal and pediatric septic shock and to target ACCM recommended therapeutic endpoints.
Fluid Sparing Resuscitation Strategy
The treating physician and medical team are advised to follow the assigned Fluid Sparing Resuscitation Strategy to guide decisions regarding the IV/IO administration of further isotonic fluid boluses, and the timing of initiation and escalation of vasoactive medication infusions to target the therapeutic endpoints recommended in the ACCM guidelines for the resuscitation of neonatal and pediatric septic shock.
干预措施: Fluid Sparing Resuscitation Strategy (Other)
结局指标
主要结局
Difference in time to shock reversal
时间窗: This outcome can be ascertained typically within 14 days of randomization
Difference (in hours) in time to shock reversal between the two study groups. Not available where death occurs while still in shock, or if the patient is placed on mechanical circulatory support for refractory shock.
次要结局
- Mortality Measures(28-, 90- day, hospital mortality)
- Complications possibly attributable to fluid overload or third spacing of fluids - Pulmonary edema(Intervention Period (from randomization until shock is reversed; typically within 14 days))
- Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score(28 days)
- Measures of Organ Dysfunction - Acute Kidney Injury(28 days)
- Measures of Organ Dysfunction - Ventilator Free Days(28 days)
- Complications possibly attributable to fluid overload or third spacing of fluids - Soft tissue edema(Intervention Period (from randomization until shock is reversed; typically within 14 days))
- Complications possibly attributable to fluid overload or third spacing of fluids - Pleural effusion requiring drainage(Intervention Period (from randomization until shock is reversed; typically within 14 days))
- Complications possibly attributable to fluid overload or third spacing of fluids - Abdominal Compartment Syndrome(Intervention Period (from randomization until shock is reversed; typically within 14 days))
- Complications possibly attributable to fluid overload or third spacing of fluids - Diuretic Exposure(From randomization until 7 days after shock is reversed)
- Complications possibly attributable to inotrope/vasopressor use - Clinical signs of digital tissue schema(Intervention Period (from randomization until shock is reversed; typically within 14 days))
- Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation(90 days)
- Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion(From randomization until 7 days after shock is reversed)
- Critical Care Treatments as binary measurement yes/no(Intervention Period (from randomization until shock is reversed; typically within 14 days))
- Paediatric Intensive Care Unit Length of Stay(Up to 90 days)
- Hospital Length of Stay(Up to 90 days)
- Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate(28 days)
研究者
Melissa Parker
Associate Professor of Pediatrics, McMaster University; Staff Physician, McMaster Children's Hospital
McMaster University