Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Improvement of ischemia
研究概览
简要总结
Minimal invasive intra-arterial prostaglandin therapy is currently being offered as an established and safe treatment approach for Non-occlusive mesenteric ischemia (NOMI). So far, there are no data that prospective evaluate clinical response parameters of this method and corresponding criteria for response.
The investigators are therefore planning a prospective observational study on NOMI patients with the aim to collect
- routine clinical data,
- data from advanced angigraphic imaging and
- data from blood biomarkers of intestinal ischemia before/at implementation of intra-arterial vasodilatory therapy.
From these three data packages, the investigators hope to subsequentially derive criteria to better predict response to therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •persistent shock: Norepinephrine dose > 0.2ug/kg/min over > 48hrs
- •intestinal failure: paralytic ileus > 24hrs despite neostigmine therapy or
- •new onset progressive organ failure (2 out of six criteria): Norepinephrine dose increase, rise in serum lactate, decrease in Horowitz index, new renal replacement therapy, rise in bilirubin, rise in INR, or all of the following: rise in ALT, AST, CK and LDH
排除标准
- •patients < 18 years old
- •pregnancy
研究组 & 干预措施
Intra-arterial Prostglandin therapy
Minimal invasive Cannulation of the Superior Mesenteric Artery (SMA) and subsequent intra-arterial application of prostaglandin E1 (Initial Bolus 20ug, followed by continuous Infusion of 60-80ug/24hr for 24-72hrs)
干预措施: Prostavasin (Drug)
结局指标
主要结局
Improvement of ischemia
时间窗: 24 hours following intervention
Lactate reduction \> 2mmol/l from baseline
次要结局
- simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI(immediately following first intra-arterial bolus)
- peak density (PD) as measured by 2D perfusion angiography(immediately following first intra-arterial bolus)
- area under the curve (AUC) as measured by 2D perfusion angiography(immediately following first intra-arterial bolus)
- time to peak (TTP) as measured by 2D perfusion angiography(immediately following first intra-arterial bolus)
- intestinal fatty acid-binding protein (I-FABP), smooth muscle protein of 22kDa (SM22) liver fatty acid-binding protein (L-FABP)(24 hours following intervention)
- 28-day mortality(28 days following intervention)
- Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours(24 hours following intervention)