REPERFUSE: Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia
Study Details
Study Description
Brief Summary
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
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routine clinical data,
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data from advanced angigraphic imaging and
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Drug: Prostavasin
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)
|
Outcome Measures
Primary Outcome Measures
- Improvement of ischemia [24 hours following intervention]
Lactate reduction > 2mmol/l from baseline
Secondary Outcome Measures
- 28-day mortality [28 days following intervention]
key secondary outcome
- Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours [24 hours following intervention]
as indicator of Shock reversal
- simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI [immediately following first intra-arterial bolus]
angiographic characteristics of vasodilation following Initial Prostaglandin bolus
- peak density (PD) as measured by 2D perfusion angiography [immediately following first intra-arterial bolus]
angiographic characteristics of vasodilation following Initial Prostaglandin bolus
- area under the curve (AUC) as measured by 2D perfusion angiography [immediately following first intra-arterial bolus]
angiographic characteristics of vasodilation following Initial Prostaglandin bolus
- time to peak (TTP) as measured by 2D perfusion angiography [immediately following first intra-arterial bolus]
angiographic characteristics of vasodilation following Initial Prostaglandin 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]
markers of ischemic intestinal barrier dysfunction
Eligibility Criteria
Criteria
Inclusion Criteria:
- persistent shock: Norepinephrine dose > 0.2ug/kg/min over > 48hrs
and
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intestinal failure: paralytic ileus > 24hrs despite neostigmine therapy or
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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:
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patients < 18 years old
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pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hannover Medical School | Hannover | Lower Saxony | Germany | 30625 |
Sponsors and Collaborators
- Hannover Medical School
Investigators
- Principal Investigator: Markus Busch, MD, Clinic for gastroenterology and hepatology
- Principal Investigator: Klaus Stahl, MD, Clinic for nephrology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REPERFUSE_8092_BO_S_2018