Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia

Overview

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.

Full Title of Study: “Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Improvement of ischemia
    • Time Frame: 24 hours following intervention
    • Lactate reduction > 2mmol/l from baseline

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Hannover Medical School
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Markus Busch, MD, Principal Investigator, Clinic for gastroenterology and hepatology
    • Klaus Stahl, MD, Principal Investigator, Clinic for nephrology

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