How well certain signs in the body (biomarkers) can help doctors figure out if someone has a condition where blood flow to their abdomen is not working properly (abdominal ischemia).
| ISRCTN | ISRCTN29102136 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29102136 |
| Secondary identifying numbers | NIl known |
- Submission date
- 04/04/2023
- Registration date
- 23/06/2023
- Last edited
- 23/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Acute mesenteric ischemia (AMISH) is an urgent medical condition resulting from the blockage of the superior mesenteric artery at its beginning or in the proximal part at the junction or in its peripheral branches. Some triggers and disease states in which obstruction is more common are known. Currently there aren`t well-defined clinical and laboratory prognostic factors that could be used to predict the course of the disease. The use of serum markers in the diagnosis of AMISH is quite limited. Given the high heterogeneity between studies, it is difficult to suggest a single marker for AMISH diagnosis.
Treatment of AMI in the early stages of the disease may be endovascular, with no known prognostic factors to predict the course of the disease, the extent of ischemia, and possible subsequent complications due to re-supply of blood in the same nourishing area. There are no clear recommendations in the literature for appropriate therapeutic action.
The purpose of the research is to analyze clinical, biochemical and radiological factors that could be used to predict the course of the disease, the occurrence of complications and the short-term and long-term consequences of superior mesenteric artery occlusion (AMISH).
Who can participate?
Adult (person over the age of 18) with acute mesenteric ischemia who are willing to participate, without any hematological, oncological or immunological disorder.
What does the study involve?
The study will involve patients who have acute mesenteric ischemia, which will be diagnosed using clinical presentation, radiological methods, and blood analysis. The patients will be divided into three groups, including two investigative groups and a control group. The investigative groups will receive either non-surgical or surgical treatment, while the control group will not have acute mesenteric ischemia. Blood samples will be taken at admission, diagnosis, and at various points during treatment to analyze factors like time since onset, medical history, medications, and specific blood markers. Patients in the surgical treatment group will also undergo a histopathological analysis of the resected bowel, and the results will be compared to blood samples from the other groups.
What are the possible benefits and risks of participating?
With the help of participating patients, we will be able to have a more precise insight and better understanding the importance of markers in the diagnosis of acute mesenteric ischemia. By comparing different diagnostic tools and analysis, we hope to indicate the course of the disease and may change the course of diagnostic and therapeutic algorithms in the occurrence of acute mesenteric ischemia (AMISH). There isn`t a health hazard for participation.
Where is the study run from?
This study is ongoing at the Abdominal Surgery Department and Clinical Institute of Radiology at the University Medical Center of Ljubljana (Slovenia)
When is the study starting and how long it is expected to run for?
November 2020 to December 2023
Who is funding the study?
University Medical Center Ljubljana (Slovenia)
Who is the main contact?
Assistant Dr Aleksandar Zafirovski, aleksandarzafirovski5@gmail.com
Docent. Dr Tadeja Pinter, tadeja.pintar@kclj.si
Docent. Dr. Dimitrij Kuhelj, dimitrij.kuhelj@guest.arnes.si
Contact information
Principal Investigator
Vojkova Cesta 15
Ljubljana
1000
Slovenia
 ORCID ID |
0000-0002-1259-688X |
|---|---|
| Phone | +386 70294736 |
| aleksandarzafirovski5@gmail.com |
Study information
| Study design | Single center observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital, Laboratory, Medical and other records |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Predictive value of biomarkers for the assessment of intestinal ischemia |
| Study acronym | AMISH |
| Study objectives | H1. The concentration of observed markers is related to the degree and duration of ischemia. H2. The concentration of the observed markers is related to the radiological criteria that determine the degree of ischemia. H3. The release of the observed biomarkers in the superior mesenteric artery is due to ischemia, due to obstruction of the lumen; the concentration of markers in mixed peripheral venous blood and in the area of narrowing (intraarterial) is different due to the different mechanism of ischemia. |
| Ethics approval(s) | Approved 03/11/2020, Komisija Republike Slovenije za medicinsko etiko (Commission of the Republic of Slovenia for Medical Ethics, Štefanova ulica 5, 1000 Ljubljana; +386 1 478 69 06; kme.mz@gov.si), ref: 0120-379 / 2020-5 |
| Health condition(s) or problem(s) studied | Early prediction and diagnosis of acute mesenteric ischemia |
| Intervention | The prospectively planned study will include patients in whom acute mesenteric ischemia will be demonstrated by clinical presentation, radiological methods (ultrasound, CT - computed tomography, CTA - CT angiography), analysis of blood factors. Depending on the course of the disease, patients will be divided into two investigative groups and a control group: 1. Investigative group: non-surgically treated patients with interventional radiology techniques. 2. Investigative group: surgically treated patients who will be operated on with known and established surgical techniques (exploratory laparotomy, segmental resection of the ischemic bowel with anastomosis / terminal stoma, re-delayed laparotomy). 3. Control group: patients who do not have acute mesenteric ischemia and in whom we will determine the level of observed chemical factors in the peripheral blood. A blood sample will be taken at admission and diagnosis of AMISH, 24 hours after. The level of observed markers will be removed in the observed groups 24 hours after diagnosis of AMISH regardless of the type of therapeutic response and in patients with delayed re-exploratory laparotomy before reoperation and 48 hours after exploratory laparotomy when bowel resection is not required. Among the observed factors we will analyze: *Time since the onset of clinical signs of the disease (ischemic pain); *Anthropometric factors, *Associated diseases, *Drug treatment, *Bioimpedance measurements, *Differential blood status, LDH, AST, ALT, Fibrinogen, activated partial thromboplastin time, INR, CRP, PCT, D-dimer, I-FABP, D-Lactate, IL-6, Citrulline, DAO, GLP-1, VEGF, HIF1A. Histopathological analysis of the resected bowel will be performed in patients in study group 2; we will determine specific histopathological indicators and the level of Il-6 in the tissue sample. The results will be compared with the level of observed factors in the peripheral venous blood and in patients from the first study group from a blood sample from the superior mesenteric artery, which will be taken during the intervention. Statistical data analysis will be performed: multivariate model of logistic regression, Mann - Whitney test for nonparametric variables and analysis of variables, t-test for parametric variables, Cox regression, model for survival analysis and identification of predictive factors. If the sample is large enough, we will additionally use data mining. |
| Intervention type | Not Specified |
| Primary outcome measure | Measured by blood sample at baseline and 24 hours: Differential blood status, LDH, AST, ALT, Fibrinogen, activated partial thromboplastin time, INR, CRP, PCT, D-dimer, I-FABP, D-Lactate, IL-6, Citrulline, DAO, GLP-1, VEGF, HIF1A |
| Secondary outcome measures | Measured using patient records at single time point: 1. Body weight (kg), Height (cm), BMI (kg/m²) 2. Symptom and medication history 3. Pain intensity (VAS 0 - 10) and duration 4. Findings from CT angiography of abdomen and pelvis 5. Surgical treatment, complications, follow up surgery 6. Lenght of stay (days) |
| Overall study start date | 03/11/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Age: Over 18 years 2. Consent to take part |
| Key exclusion criteria | 1. Oncological disorders 2. Immunological disorders 3. Hematological disorders |
| Date of first enrolment | 20/12/2022 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
Ljubljana
1000
Slovenia
Sponsor information
Hospital/treatment centre
Zaloška cesta 2, Slovenia
Ljubljana
1000
Slovenia
| Phone | +386 (01) 522 50 50 |
|---|---|
| gp.ukc@kclj.si | |
| Website | https://www.kclj.si/ |
"ROR" |
https://ror.org/01nr6fy72 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from: Assistant Dr. Aleksandar Zafirovski aleksandarzafirovski5@gmail.com |
Editorial Notes
17/05/2023: Trial's existence confirmed by Komisija Republike Slovenije za medicinsko etiko (Commission of the Republic of Slovenia for Medical Ethics)
