NCT04235634

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. 1.routine clinical data,
  2. 2.data from advanced angigraphic imaging and
  3. 3.data from blood biomarkers of intestinal ischemia before/at implementation of intra-arterial vasodilatory therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

January 13, 2020

Last Update Submit

February 28, 2022

Conditions

Non-Occlusive Mesenteric Ischaemia (NOMI)

Keywords

Non-occlusive mesenteric ischemiaShockIntra-arterial prostglandin therapy

Outcome Measures

Primary Outcomes (1)

  • Improvement of ischemia

    Lactate reduction \> 2mmol/l from baseline

    24 hours following intervention

Secondary Outcomes (7)

  • 28-day mortality

    28 days following intervention

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

    24 hours following intervention

  • simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI

    immediately following first intra-arterial bolus

  • peak density (PD) as measured by 2D perfusion angiography

    immediately following first intra-arterial bolus

  • area under the curve (AUC) as measured by 2D perfusion angiography

    immediately following first intra-arterial bolus

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

ProstavasinDRUG

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)

Intra-arterial Prostglandin therapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • \- 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

You may not qualify if:

  • patients \< 18 years old
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

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

    PMID: 35379286DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Shock

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Markus Busch, MD

    Clinic for gastroenterology and hepatology

    PRINCIPAL INVESTIGATOR

  • Klaus Stahl, MD

    Clinic for nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 22, 2020

Study Start

October 1, 2018

Primary Completion

December 31, 2021

Study Completion

February 1, 2022

Last Updated

March 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)