Clinical trial NCT04235634: Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia
Official title: Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Occlusive Mesenteric Ischaemia (NOMI)
Keywords: Non-occlusive mesenteric ischemia
Shock
Intra-arterial prostglandin therapy
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU with persistent shock, intestinal failure as well as new onset and progressive organ failure with a CT and angiography based diagnosis of Non-occlusive mesenteric ischemia (NOMI)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of ischemia
timeFrame: 24 hours following intervention
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days following intervention
measure: Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours
timeFrame: 24 hours following intervention
measure: simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI
timeFrame: immediately following first intra-arterial bolus
measure: peak density (PD) as measured by 2D perfusion angiography
timeFrame: immediately following first intra-arterial bolus
measure: area under the curve (AUC) as measured by 2D perfusion angiography
timeFrame: immediately following first intra-arterial bolus
measure: time to peak (TTP) as measured by 2D perfusion angiography
timeFrame: immediately following first intra-arterial bolus
measure: intestinal fatty acid-binding protein (I-FABP), smooth muscle protein of 22kDa (SM22) liver fatty acid-binding protein (L-FABP)
timeFrame: 24 hours following intervention
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Clinic for gastroenterology and hepatology
name: Markus Busch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for nephrology
name: Klaus Stahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rittgerodt N, Pape T, Busch M, Becker LS, Schneider A, Wedemeyer H, Seeliger B, Schmidt J, Hunkemoller AM, Fuge J, Knitsch W, Fegbeutel C, Gillmann HJ, Meyer BC, Hoeper MM, Hinrichs JB, David S, Stahl K. Predictors of response to intra-arterial vasodilatory therapy of non-occlusive mesenteric ischemia in patients with severe shock: results from a prospective observational study. Crit Care. 2022 Apr 4;26(1):92. doi: 10.1186/s13054-022-03962-w.