Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia

Completed

• Conditions: Non-Occlusive Mesenteric Ischaemia (NOMI)
• Interventions: Drug: Prostavasin

• Registration Number: NCT04235634
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-22
• Primary Completion: 2021-12-31
• Status Verified: 2022-02
• Study Completion: 2022-02-01
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intra-arterial Prostglandin therapy	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)

Primary Outcome Measures

Name	Time	Method
Improvement of ischemia	24 hours following intervention	Lactate reduction \> 2mmol/l from baseline

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28 days following intervention	key secondary outcome
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
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
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
Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours	24 hours following intervention	as indicator of Shock reversal

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany