Paramedic Initiated Treatment of Sepsis Targeting Out-of-hospital Patients (PITSTOP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,061
- 试验地点
- 8
- 主要终点
- Primary outcome: mortality prior to hospital discharge to day 90.
研究概览
简要总结
Sepsis occurs when a serious infection - most commonly infection of the lungs, urinary system, or blood - leads to acute organ failure. It is a common, expensive, and frequently lethal condition. A growing body of evidence suggests that early recognition and treatment of sepsis can improve survival.
Unfortunately, many patients with sepsis do not receive key therapies until physicians working in Emergency Departments have assessed them - often introducing marked delays. It is estimated that one-half of patients with sepsis are treated and transported to hospital by paramedics. This allows paramedics a unique opportunity to provide early treatment at the initial point of patient contact, thereby decreasing the time to treatment for these critically ill patients. This randomized controlled trial will evaluate whether prompt recognition followed by early antibiotics and/or intravenous fluids delivered by paramedics in the field leads to improved survival, compared to usual care, for patients who are transported to the hospital with sepsis.
详细描述
The ultimate goal of this research program is to evaluate a fundamental change in the delivery of sepsis care. Currently, patients with severe sepsis do not receive key evidence-based therapies until they have been assessed in emergency departments - often introducing considerable delays. This research tests whether integrating paramedics directly into a chain-of-survival for sepsis will improve outcomes for these critically ill patients. In essence, this research seeks to break down silos of care, delivering sepsis treatments based on when they are needed, rather than on where the patient is physically located. If the trial is positive, the results will have broad implications for other health systems by showing that prehospital identification and treatment of sepsis increases the number of patients that survive this life-threatening condition. If the trial fails to demonstrate effectiveness of prehospital sepsis treatments, it will ensure that resources are not needlessly invested in large-scale implementations of paramedic sepsis protocols, as has been done in several other jurisdictions. A lack of benefit would also cast doubt on the observational data suggesting that early antibiotics are important, and suggest a more restrained approach to empiric antibiotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study drug and placebo are prepared in identical masked containers.
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
- •Patients with Sepsis, defined as (all 3 must be present): i) Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tract infection, skin infection, bone and joint infection, intra-abdominal infection, meningitis ii) Presence of fever: Temperature ≥ 38.0°C measured by paramedic or history of fever during previous 24 hours iii) Presence of hypotension: Systolic blood pressure < 100mmHg
- •Age ≥ 18 years
排除标准
- •Post cardiac arrest
- •Suspected ST-segment elevation myocardial infarction (STEMI)
- •Suspected acute cerebrovascular accident (CVA)
- •Acute severe trauma
- •Obvious severe non-traumatic bleeding
- •Signs of fluid overload
- •Suspected acute congestive heart failure (CHF)
- •Known Clostridium difficile infection within the last 6 weeks
- •Known pregnancy or breastfeeding
- •Known allergy or sensitivity to penicillin or cephalosporin
- •Known to be receiving oral or subcutaneous anticoagulants or low molecular weight heparin
- •Paramedic is unable to identify patient by first and last name and/or health card number
研究组 & 干预措施
Comparison 1: Prehospital Ceftriaxone
1g of Ceftriaxone will be administered by immediate intramuscular (IM) injection. The drug is provided in a sterile and completely covered vial as a white, odourless powder
干预措施: Comparison 1: Prehospital Ceftriaxone (Drug)
Comparison 1: Placebo
The placebo is provided in a sterile and completely covered vial.
干预措施: Comparison 1: Placebo (Drug)
Comparison 2: Liberal fluids
Paramedics will administer up to 2 litres of intravenous 0.9% saline solution to all participants in this arm regardless of blood pressure, reassessing for signs of volume overload after each 250ml.
干预措施: Comparison 2: Liberal fluids (Drug)
Comparison 2: Conservative fluids
Paramedics will administer 0.9% saline solution to participants who have systolic blood pressure <90mmHg, and will only continue the infusion until the systolic blood pressure is >=100mmHg.
干预措施: Comparison 2: Conservative fluids (Drug)
结局指标
主要结局
Primary outcome: mortality prior to hospital discharge to day 90.
时间窗: 90 days
Dichotomous outcome reported as percentage
次要结局
- Mortality at 90 days after enrollment(90 days after enrollment)
- Organ dysfunction during first 24 hours (mechanical ventilation, vasopressor therapy (any), dialysis(24 hours)
- Organ dysfunction during hospitalization (mechanical ventilation)(until hospital discharge, measured up to maximum of day 90)
- duration of hospital admission (if any)(until hospital discharge, measured up to maximum of day 90)
- duration of first ICU admission (if any)(until ICU discharge, measured up to maximum of day 90)
- Proportion of patients with positive blood cultures obtained in hospital(24 hours)
- Proportion of patients receiving antibiotics within first 24 hours of hospitalization(24 hours)
- Microbiology results (if any)(24 hours)
- Frequency distribution and mean time to first dose of antibiotics (if any) within first 24 hours of hospitalization(24 hours)
- Proportion of patients receiving IV fluids (>250mL) within first 24 hours of hospitalization(24 hours)
- Total amount of IV fluids administered during transport and first 24 hours of hospitalization (if any)(24 hours)
- Proportion of patients with pulmonary edema identified during transport to hospital and on initial chest x-ray(during transport and on initial chest x-ray (if completed))
- Proportion of patients with blood, urine, sputum cultures that grow organisms resistant to ceftriaxone(24 hours)
- Proportion of patients diagnosed with sepsis or infection by emergency department physician(during admission)
- Proportion of hospitalized patients who grow any antibiotic-resistant organism (methicilin resistant S. aureus, Clostridium difficile, extended beta-lactamase resistant organisms)(during admission)
- Proportion of patients with anaphylaxis or suspected allergic reactions to study medication(during admission)
研究者
Dr. Damon Scales
MD, PhD, FRCPC
Sunnybrook Health Sciences Centre