Non-Occlusive Mesenteric Ischaemia (NOMI)REPERFUSENCT04235634
Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia
An observational study of Non-Occlusive Mesenteric Ischaemia (NOMI), run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Occlusive Mesenteric Ischaemia (NOMI)
- What is being tested?
- Prostavasin
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2018to 1 Feb 2022
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- patients < 18 years old
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
- routine clinical data,
- data from advanced angigraphic imaging and
- 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.
- Being tested
- Prostavasin
- Keywords
- Non-occlusive mesenteric ischemia, Shock, Intra-arterial prostglandin therapy
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Prostavasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of ischemia
Lactate reduction > 2mmol/l from baseline
Measured: 24 hours following intervention
Secondary outcomes (7)
28-day mortality
key secondary outcome
Measured: 28 days following intervention
Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours
as indicator of Shock reversal
Measured: 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
Measured: immediately following first intra-arterial bolus
peak density (PD) as measured by 2D perfusion angiography
angiographic characteristics of vasodilation following Initial Prostaglandin bolus
Measured: 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
Measured: immediately following first intra-arterial bolus
time to peak (TTP) as measured by 2D perfusion angiography
angiographic characteristics of vasodilation following Initial Prostaglandin bolus
Measured: 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
Measured: 24 hours following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Oct 2018
- Primary completion31 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Occlusive Mesenteric Ischaemia (NOMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Busch, MD, Principal investigator, Clinic for gastroenterology and hepatologyKlaus Stahl, MD, Principal investigator, Clinic for nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235634
- Sponsor's protocol ID
- REPERFUSE_8092_BO_S_2018
- Acronym
- REPERFUSE
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35379286
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intra-arterial Prostaglandin Therapy in Non-occlusive Mesenteric Ischemia (NOMI)
- ClinicalTrials.gov ID
- NCT04235634
- Acronym / sponsor ID
- REPERFUSE / REPERFUSE_8092_BO_S_2018
- Keywords
- Non-occlusive mesenteric ischemia, Shock, Intra-arterial prostglandin therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- routine clinical data,
- data from advanced angigraphic imaging and
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial Prostglandin therapy | – | Drug: ProstavasinMinimal 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients < 18 years old
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProstavasinMinimal 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 | Intra-arterial Prostglandin therapy |
Primary outcome
Improvement of ischemia
Time frame: 24 hours following intervention
Lactate reduction > 2mmol/l from baseline
7 secondary outcomes
28-day mortality
Time frame: 28 days following intervention
Change of norepinephrine dose in microgram/kg/min from baseline at 24 hours
Time frame: 24 hours following intervention
simplified NOMI score, range 0-7 points with higher scores indicating more severe NOMI
Time frame: immediately following first intra-arterial bolus
peak density (PD) as measured by 2D perfusion angiography
Time frame: immediately following first intra-arterial bolus
area under the curve (AUC) as measured by 2D perfusion angiography
Time frame: immediately following first intra-arterial bolus
time to peak (TTP) as measured by 2D perfusion angiography
Time frame: 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)
Time frame: 24 hours following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 35379286Rittgerodt 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.
- Individual participant dataSharing planned: No
Related trials for Non-Occlusive Mesenteric Ischaemia (NOMI)
RecruitingObservational study
Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia
Non-Occlusive Mesenteric Ischaemia (NOMI), Acute Mesenteric Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Busch, MD principal investigator
Clinic for gastroenterology and hepatology
Klaus Stahl, MD principal investigator
Clinic for nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Occlusive Mesenteric Ischaemia (NOMI), run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of ischemia (time frame: 24 hours following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.