Non-Occlusive Mesenteric Ischaemia (NOMI) Clinical Trial
— REPERFUSEOfficial title:
Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)
| Verified date | February 2022 |
| Source | Hannover Medical School |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | February 1, 2022 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Hannover Medical School | Hannover | Lower Saxony |
| Lead Sponsor | Collaborator |
|---|---|
| Hannover Medical School |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement of ischemia | Lactate reduction > 2mmol/l from baseline | 24 hours following intervention | |
| Secondary | 28-day mortality | key secondary outcome | 28 days following intervention | |
| Secondary | Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours | as indicator of Shock reversal | 24 hours following intervention | |
| Secondary | 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 | |
| Secondary | peak density (PD) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus | |
| Secondary | 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 | |
| Secondary | time to peak (TTP) as measured by 2D perfusion angiography | angiographic characteristics of vasodilation following Initial Prostaglandin bolus | immediately following first intra-arterial bolus | |
| Secondary | 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 |