Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (REPERFUSE)

Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)

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.

Study Overview

• Status: Completed
• Conditions: Non-Occlusive Mesenteric Ischaemia (NOMI)
• Intervention / Treatment: Drug: Prostavasin

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Hannover, Lower Saxony, Germany, 30625
      • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of ischemia	Lactate reduction > 2mmol/l from baseline	24 hours following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	key secondary outcome	28 days following intervention
Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours	as indicator of Shock reversal	24 hours following intervention
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
peak density (PD) as measured by 2D perfusion angiography	angiographic characteristics of vasodilation following Initial Prostaglandin bolus	immediately following first intra-arterial bolus
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
time to peak (TTP) as measured by 2D perfusion angiography	angiographic characteristics of vasodilation following Initial Prostaglandin bolus	immediately following first intra-arterial bolus
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Markus Busch, MD, Clinic for gastroenterology and hepatology; Principal Investigator: Klaus Stahl, MD, Clinic for nephrology

Publications and helpful links

General Publications

• Rittgerodt N, Pape T, Busch M, Becker LS, Schneider A, Wedemeyer H, Seeliger B, Schmidt J, Hunkemöller 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Shock; Non-occlusive mesenteric ischemia; Intra-arterial prostglandin therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Ischemia; Mesenteric Ischemia; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: REPERFUSE_8092_BO_S_2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No