Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)

Conditions
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Non-Occlusive Mesenteric Ischaemia (NOMI)

Intervention / Treatment
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* Drug: Prostavasin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - persistent shock: Norepinephrine dose > 0.2ug/kg/min over > 48hrs and 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 Exclusion Criteria: patients < 18 years old pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intra-arterial Prostglandin therapy<br>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) | Drug: Prostavasin<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of ischemia | Lactate reduction > 2mmol/l from baseline | 24 hours following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | key secondary outcome | 28 days following intervention | 
| Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours | as indicator of Shock reversal | 24 hours following intervention | 
| simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus | 
| peak density (PD) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus | 
| area under the curve (AUC) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus | 
| time to peak (TTP) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | 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) | markers of ischemic intestinal barrier dysfunction | 24 hours following intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-occlusive mesenteric ischemia, Shock, Intra-arterial prostglandin therapy