Pediatric Intensive Care Ulcer Prophylaxis Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 7
- 主要终点
- Effective screening
研究概览
简要总结
This study tests the feasibility of a large study of stress ulcer prophylaxis in critically ill children. Children admitted to the Pediatric Intensive Care Unit who are expected to require mechanical ventilation for more than 48 hours will be randomized to intravenous pantoprazole 1 mg/kg or matching placebo once daily until they no longer need mechanical ventilation.
详细描述
Despite sparse pediatric data on the effectiveness of stress ulcer prophylaxis to prevent gastrointestinal (GI) bleeding, 60% of critically ill children receive these medications. This may have unintended consequences - increasing the risk of nosocomial infections - which may be more serious and common than bleeding these drugs are prescribed to prevent. A large randomized trial (RCT) is needed to assess the balance of these risks and benefits, to determine if a strategy of withholding stress ulcer prophylaxis in critically ill children is not inferior to a strategy of routine stress ulcer prophylaxis. RCTs in pediatric critical care are exceptionally challenging to complete; thus, a rigorous pilot RCT is crucial. The pilot may prevent pursuit of a trial that is ultimately not feasible - which is ethically and financially responsible. It is more likely that this carefully designed pilot trial will ensure that the larger trial we undertake is successful.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 18 years of age
- •>4 months of age
- •requires respiratory support in the form of invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen
- •the attending physician expects the child to require respiratory support for at least 2 more days
排除标准
- •histamine-2 receptor antagonist (H2RA) or proton pump inhibitor (PPI) use for >1 week in the past month
- •active GI bleeding Blood in the nasogastric (NG) tube or coffee-ground emesis suspected by the attending physician to be from the oropharynx is not an exclusion criterion.
- •documented severe reflux, active H. pylori infection, severe esophagitis, Zollinger Ellison syndrome, Barrett's esophagus, peptic ulcer bleeding within 8 weeks
- •are receiving methylprednisolone 15 mg/kg/day or more (or equivalent) Equivalent doses: methylprednisolone, prednisone or prednisolone 15 mg/kg/day; dexamethasone 3 mg/kg/day; hydrocortisone 60 mg/kg/day
- •are receiving mycophenolate (enteral), methotrexate, nelfinavir, atazanavir, saquinavir, posaconazole
- •chronic ventilation on usual pressure settings and rate
- •nocturnal or intermittent non-invasive ventilation only
- •are eating, nursing, or if chronically fed via feeding tube, receiving usual feeds
- •received more than 1 daily-dose equivalent of acid suppressive medication in the PICU
- •were previously enrolled in this trial
- •are currently enrolled in a potentially confounding trial
- •are known to be pregnant or breastfeeding
- •are known to be allergic to pantoprazole or any other ingredient in the product
- •are not expected to survive this PICU admission because of palliative care or limited life support
研究组 & 干预措施
pantoprazole
pantoprazole 1 mg/kg (maximum 40 mg) IV once daily until the participants no longer need mechanical ventilation - to a maximum of 30 days or until Pediatric Intensive Care Unit (PICU) discharge.
干预措施: Pantoprazole (Drug)
placebo (for pantoprazole)
an equivalent volume of normal saline IV once daily until the participants no longer need mechanical ventilation - to a maximum of 30 days or until PICU discharge.
干预措施: Placebo (for pantoprazole) (Drug)
结局指标
主要结局
Effective screening
时间窗: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if \>80% of eligible patients are approached for consent.
Timely enrollment
时间窗: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if \>80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.
Participant accrual
时间窗: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if the average monthly enrollment is 2 or more participants per centre.
Protocol adherence
时间窗: During admission to the Pediatric Intensive Care Unit (to maximum of 30 days)
We will consider the trial feasible if \>90% of doses are administered according to the protocol.
次要结局
- Clinically important bleeding(During admission to the Pediatric Intensive Care Unit (to maximum of 30 days))
- Nosocomial infections(During admission to the Pediatric Intensive Care Unit (to maximum of 30 days))
- Other gastrointestinal bleeding(During admission to the Pediatric Intensive Care Unit (to maximum of 30 days))