Non-Occlusive Mesenteric Ischaemia (NOMI)
Conditions
Keywords
Non-occlusive mesenteric ischemia, Shock, Intra-arterial prostglandin therapy
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 1. routine clinical data, 2. data from advanced angigraphic imaging and 3. 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.
Interventions
DRUGProstavasin
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)
Sponsors
Hannover Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of ischemia | 24 hours following intervention | Lactate reduction \> 2mmol/l from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 28-day mortality | 28 days following intervention | key secondary outcome |
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed