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NCT Number: NCT04235634

Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia

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.

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Key information

Conditions

Non-Occlusive Mesenteric Ischaemia (NOMI) Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostavasin

Drug

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 outcomes

  1. Improvement of ischemia

    Time frame: 24 hours following intervention

    Lactate reduction > 2mmol/l from baseline

Secondary outcomes

  1. 28-day mortality

    Time frame: 28 days following intervention

    key secondary outcome

  2. Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours

    Time frame: 24 hours following intervention

    as indicator of Shock reversal

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Acronym: REPERFUSE

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jan 22, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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