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

Hannover Medical School (MHH)

Status: Completed

Conditions: Non-Occlusive Mesenteric Ischaemia (NOMI)

Treatments: Drug: Prostavasin

Study type: Observational

Funder types: Other

Identifiers

NCT04235634

REPERFUSE_8092_BO_S_2018

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 1 patient group

Intra-arterial Prostglandin therapy

Description:

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)

Treatment:

Drug: Prostavasin