Single-center, Proof of Concept, Prospective Study Evaluating the Utility of RELiZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days
研究概览
简要总结
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion.
RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.
详细描述
This is a double-blind, placebo-controlled, parallel design study. A total of 32 adult patients who have been admitted to the Surgical or Medical Intensive Care Unit with evidence of MOF (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission) and who have not yet been initiated on enteral nutrition or were initiated on enteral nutrition up to 48 hours prior.
After informed consent has been obtained, two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 - 89 years of age.
- •Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission).
- •Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. Enteral nutrition support defined as support planned to be given via any route connected to the gastrointestinal system (i.e., the enteral route). This includes tube feeding using nasogastric, nasoduodenal, gastrostomy, jejunostomy tubes, or similar.
- •Patients who lack the capacity to consent for themselves may be included upon receiving consent from their legally authorized representatives.
排除标准
- •Pregnant women and prisoners.
- •Hypotension is attributed to suspected or confirmed cardiogenic shock.
- •Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition.
- •Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated.
- •C. Difficile or other gastrointestinal infection that may manifest with diarrhea.
- •Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
- •Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.
研究组 & 干预措施
RELiZORB
RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.
干预措施: RELiZORB™ (Device)
Placebo
Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days
时间窗: Duration of intervention (5 days)
Efficacy will be assessed by the total calories administered, expressed as the percentage of goal nutrition calories achieved daily, compared between the two groups over the five-day study period
次要结局
- Number of intolerance-related enteral nutrition pauses(Duration of intervention (5 days))
- Insulin units used(Duration of intervention (5 days))
- Change in fecal elastase(From Baseline to end of intervention at 5 days)