Searching Biomarkers of Acute Intestinal Ischemic Injuries (Survibio)
Primary Purpose
Acute Mesenteric Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Mesenteric Ischemia
Eligibility Criteria
Inclusion Criteria:
- age> 18 years
- Acute abdominal pain requiring an injected abdominal injected CT scan, at best at non-injected / early arterial / portal time
- Admitted or attended in Beaujon and / or Bichat hospitals
- Patient covered by a social security scheme
- Written consent
Exclusion Criteria:
• lack of abdominal CT scan
Sites / Locations
- Corcos OlivierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient
witness
Arm Description
Any patient admitted for acute abdomen condition with or without ischemic causes.
Outcomes
Primary Outcome Measures
observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause
Secondary Outcome Measures
mortality and causes
Intestinal resection ratio
acute intestinal ischemic injury relapse ratio
short gut syndrome features
persistency of mesenteric ischemia clinical signs or of ischemic gastric stenosis
Full Information
NCT ID
NCT03518099
First Posted
April 25, 2018
Last Updated
December 26, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03518099
Brief Title
Searching Biomarkers of Acute Intestinal Ischemic Injuries
Acronym
Survibio
Official Title
Searching Biomarkers of Acute Intestinal Ischemic Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
May 22, 2020 (Anticipated)
Study Completion Date
May 22, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the SURVIBIO study is to characterize accurate biomarkers for acute mesenteric ischemia, in particular at early stages.
In the study, the development of biomarkers will be based on the analysis of human biological samples from patients and controls that will be conserved in a biological library. Samples will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148), in the Department of Biochemistry (Pr Puy, Dr Peoc'h), in Paris V university , in Imperial College of London (Pr Dumas), in Jacques Monod Institute and in Maastricht University Medical Center . The candidate markers will be determined according to an a priori method (form markers already described in the literature) and with no a priori strategy using -omics methods.
Detailed Description
Acute intestinal ischemic injury (i3), or intestinal infarction, is an extremely severe condition that affects the intestine, with a mortality rate that is over 80%, and with major anatomical and functional consequences for the surviving patients, mainly because of intestinal resections, which are responsible for chronic intestinal failure, long term parenteral nutrition and an important financial impact on public health.
Even though the incidence of i3 is largely underestimated (mainly because of the lack of knowledge of diagnostic), more than 1000 patients have been surveyed in Paris's hospital through Information Systems Medicalization Program (K550) searching in 2014. Furthermore, i3 represents a digestive emergency for which the only known prognostic factors are the precocity of the diagnostic and treatment.
Investigators have opened in January 2016 the first structure for intestinal vascular emergency (SURVI) within the Groups University Hospitals Paris-Nord Val de Seine. This unique and innovative intensive care structure, which is dedicated to the multidisciplinary treatment of acute mesenteric ischemia, doesn't have any equivalent, and allows the constitution of cohorts with biological and tissular bio-banking.
SURVI provides the patients suffering from intestinal ischemia a "gut and life staving strategy", through a multimodal and multidisciplinary management (M3). M3 is based on a simple algorithm and it brings together experts in intestinal and vascular pathologies that come from different medical disciplines, such as gastroenterology, interventional radiology, vascular surgery, digestive surgery, anaesthesiology and cardiology.
Therefore, the therapeutic strategies aim to limit the complications, to protect the viable intestine, and to remove the necrotic intestine.
Beside the therapeutic strategy that is proposed by SURVI, improvement of the clinical treatment needs to be associated with the finding of new diagnostic tools of intestinal ischemia, that will have to be early, sensitive and specific, as it is the case for troponin in the context of myocardium ischemia.
So far, no biomarker that is sensible and specific enough for the early diagnostic of intestinal ischemia has been found. The CT-scan which is the only diagnostic tool that allow investigators to confirm the diagnostic, in theory, presents a lack of sensibility for the early, not complicated and non-occlusive forms of the disease.
The main prognostic factor of acute intestinal ischemia is the precocity of diagnostic and treatment. Indeed, the mortality rate sharply increases with the occurrence of intestinal necrosis. The problem is that the phases of the disease that precede intestinal necrosis are extremely difficult to diagnose without any biomarker that is sensible and specific enough. Therefore, it is of major importance for the clinician to be provided with one or more biomarker that will help to validate or invalidate the diagnostic of intestinal ischemia, in the context of any acute abdomen condition.
The aim of the SURVIBIO study is therefore to characterize biomarkers for early diagnostic of acute mesenteric ischemia.
In the prospective part of the study, the development of biomarkers will be based on analysis of human biological samples from patients and controls that will be conserved in a biological library and that will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148) and in the Department of Biochemistry (Pr Puy, Dr Peoc'h). Among the candidate markers, investigators will analyse I-FABP (molecule associated with enterocyte damage at the top of the intestinal villi), D-Lactate (which is specific of intestinal E.coli, and which indicates bacterial translocation, when found in the blood), Citrulline (which is a marker of the functional profile of enterocytes) and ischemia-modified albumin.
In addition to this approach to "candidate" markers based on very brief data from the literature, investigators also wish to develop an unconventional approach, combining a medical approach of proteomics, combining tandem spectrometry with MALDI and establishment of cytokine profile via a multi-complex approach to the emergence of new potential diagnostic biomarkers. The profiles obtained for patients with ischemia are available at profiles obtained on "control" patients, unaffected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mesenteric Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
163 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Experimental
Arm Description
Any patient admitted for acute abdomen condition with or without ischemic causes.
Arm Title
witness
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood sampling
Other Intervention Name(s)
urine sampling
Intervention Description
Two tubes of 5ml of blood will be collected for Serum collection, 3 tubes of 5 ml of blood taken for plasma collection and 2 tubes of 7 ml of blood taken for DNA collection
Primary Outcome Measure Information:
Title
observation of clinical-bio-scanographic pain related to a splanchnic-mesenteric, occlusive or non-occlusive vascular insufficiency, to abdominal CT angiography, in the absence of another identifiable cause
Time Frame
2 years
Secondary Outcome Measure Information:
Title
mortality and causes
Time Frame
2 years
Title
Intestinal resection ratio
Time Frame
2 years
Title
acute intestinal ischemic injury relapse ratio
Time Frame
2 years
Title
short gut syndrome features
Time Frame
2 years
Title
persistency of mesenteric ischemia clinical signs or of ischemic gastric stenosis
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age> 18 years
Acute abdominal pain requiring an injected abdominal injected CT scan, at best at non-injected / early arterial / portal time
Admitted or attended in Beaujon and / or Bichat hospitals
Patient covered by a social security scheme
Written consent
Exclusion Criteria:
• lack of abdominal CT scan
Facility Information:
Facility Name
Corcos Olivier
City
Clichy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Corcos
Phone
0140875695
Email
olivier.corcos@aphp.fr
First Name & Middle Initial & Last Name & Degree
Katell Peoc'h
Phone
0140875368
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Searching Biomarkers of Acute Intestinal Ischemic Injuries
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