Cardiac Surgery With Cardiopulmonary BypassaMIKINCT06365827
Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI)
An observational study of Cardiac Surgery With Cardiopulmonary Bypass and Acute Mesenteric Ischemia, run by University of Giessen at 1 site in Germany.
Trial summary
Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery With Cardiopulmonary Bypass, Acute Mesenteric Ischemia, Acute Kidney Injury
- What is being tested?
- observational study
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2022to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients undergoing cardiac or vascular surgery with extracorporeal circulation in University Hospital Giessen
Who may be able to join
- All consecutive patients undergoing cardiac or vascular surgery with extracorporeal circulation
Who cannot join
- endocarditis or bacterial sepsis,
- hepatitis or HIV on the patient\'s medical history,
- cases in which informed consent to participate in the study could not be obtained
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Giessen, Cardiovascular surgery
Giessen, Hesse, 35392
About this study
Official title: Investigation of Perioperative Assessed Biomarker I-FABP (Intestinal Fatty Acid-binding Protein) Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury Followed by Extracorporeal Circulation
Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis.
Read the detailed description
Extracorporeal circulation (ECC) in the form of cardiopulmonary bypass (CPB) counts among the contemporary strategies for organ protection during major cardiovascular surgery. Despite protecting the organs from severe ischemia-reperfusion injury, it generates a significant inflammatory response that may produce organ dysfunction. An aortic cross-clamp is a key step in open cardiovascular surgery to interrupt the blood flow across the aorta for operation. After aortic cross-clamp release, peripheral vascular resistance decreases by 70 to 80%, causing hypotension in the lower half of the body. During the ischemia-reperfusion period Oxygen-free radicals and inflammatory cytokines produced, which may contribute to inflammation-induced tissue injury. As an inflammatory reaction after the cardiac surgery involving CPB, capillary leak syndrome is associated with increased morbidity and mortality. Microcirculatory alterations in the mesenteric artery during or after CPB contribute to the intestinal hypoperfusion. A suboptimal microperfusion and ischemia-reperfusion of the intestinal tissue during ECC are the trigger of altered gut permeability and a systemic inflammatory response syndrome in turn. The main mechanism of intestinal ischemia after Cardiovascular surgery is a non-occult mesenteric ischemia (NOMI). Contrarily to occlusive mesenteric ischemia by emboli or thrombosis, NOMI is related to a reduction in the splanchnic blood flow. NOMI is considered to be a rare (incidence around 1%) but severe and very often fatal complication after a cardiac surgery with a mortality rate up to 90%, in which the perfusion of the intestine is limited. In the diagnosis of a NOMI, an invasive angiography with a digital subtraction angiography (DSA) is considered to be the gold standard. And a common therapy for it is to correct the underlying vascular pathology and diffuse vasospasm with application of vasodilators. That is performed through an angiographically and precisely placed catheter in the superior mesenteric artery. clinical appearance of NOMI presents a myriad of symptoms and can be confusing, or might even be completely masked. In addition, there is still a lack of highly sensitive and specific biomarkers to predict the NOMI.
Furthermore, patients with postoperative NOMI had significantly high coincidence for acute kidney injury (AKI). NOMI has also been shown to correlate with renal insufficiency. Metzger et al. hypothesised that similar Pathophysiological mechanisms may trigger AKI in association with NOMI.
The aim of the study is to prospectively evaluate the level of perioperatively assessed I-FABP tests for NOMI and to correlate those with clinical or angiographic findings.
- Conditions
- Cardiac Surgery With Cardiopulmonary Bypass, Acute Mesenteric Ischemia, Acute Kidney Injury, Non-Occlusive Mesenteric Ischaemia
- Being tested
- observational study
- Keywords
- Extracorporeal circulation, intestinal fatty acid-binding protein, I-FABP, acute mesenteric ischemia, acute kidney injury, non-occlusive mesenteric ischemia (NOMI), Cystatin C, NGAL
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
no intervention of interest
| Study group | Role | What they receive |
|---|---|---|
| AMI vs. non-AMI | AMI, those with a acute mesenteric ischemia vs. non-AMI, those without a condition Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of I-FABP values with/and without acute mesenteric ischemia
Is the variation of I-FABP values different in patients with and without the mesenteric ischemia at the time of initial clinical suspicion?
Measured: 24 hours before and 36 hours after surgery
Secondary outcomes (4)
Time interval to mesenteric ischemia
How does the time interval between the incident of mesenteric ischemia and the measured I-FABP tests affect the result?
Measured: 24 hours before until day 7 post-surgery
Overall mortality rate
Overall mortality rate until day 30
Measured: until day 30 post-surgery
Correlation of I-FABP with biomarkers of acute kidney injury
How does the value of I-FABP correlate with acute kidney injury?
Measured: 24 hours before until day 7 post-surgery
Association of mesenteric ischemia with hypercoagulable states
Can an increased I-FABP level in blood and urine be a predictor for procoagulatory state measured with thrombin generation assay?
Measured: 24 hours before until day 7 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery With Cardiopulmonary BypassStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365827
- Sponsor's protocol ID
- AZ293/20
- Acronym
- aMIKI
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Perioperative Assessed Biomarker I-FABP (Intestinal Fatty Acid-binding Protein) Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury Followed by Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT06365827
- Acronym / sponsor ID
- aMIKI / AZ293/20
- Conditions
- Cardiac Surgery With Cardiopulmonary Bypass, Acute Mesenteric Ischemia, Acute Kidney Injury, Non-Occlusive Mesenteric Ischaemia
- Keywords
- Extracorporeal circulation, intestinal fatty acid-binding protein, I-FABP, acute mesenteric ischemia, acute kidney injury, non-occlusive mesenteric ischemia (NOMI), Cystatin C, NGAL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Apr 2024 (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.
Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis.
Detailed description
Extracorporeal circulation (ECC) in the form of cardiopulmonary bypass (CPB) counts among the contemporary strategies for organ protection during major cardiovascular surgery. Despite protecting the organs from severe ischemia-reperfusion injury, it generates a significant inflammatory response that may produce organ dysfunction. An aortic cross-clamp is a key step in open cardiovascular surgery to interrupt the blood flow across the aorta for operation. After aortic cross-clamp release, peripheral vascular resistance decreases by 70 to 80%, causing hypotension in the lower half of the body. During the ischemia-reperfusion period Oxygen-free radicals and inflammatory cytokines produced, which may contribute to inflammation-induced tissue injury. As an inflammatory reaction after the cardiac surgery involving CPB, capillary leak syndrome is associated with increased morbidity and mortality. Microcirculatory alterations in the mesenteric artery during or after CPB contribute to the intestinal hypoperfusion. A suboptimal microperfusion and ischemia-reperfusion of the intestinal tissue during ECC are the trigger of altered gut permeability and a systemic inflammatory response syndrome in turn. The main mechanism of intestinal ischemia after Cardiovascular surgery is a non-occult mesenteric ischemia (NOMI). Contrarily to occlusive mesenteric ischemia by emboli or thrombosis, NOMI is related to a reduction in the splanchnic blood flow. NOMI is considered to be a rare (incidence around 1%) but severe and very often fatal complication after a cardiac surgery with a mortality rate up to 90%, in which the perfusion of the intestine is limited. In the diagnosis of a NOMI, an invasive angiography with a digital subtraction angiography (DSA) is considered to be the gold standard. And a common therapy for it is to correct the underlying vascular pathology and diffuse vasospasm with application of vasodilators. That is performed through an angiographically and precisely placed catheter in the superior mesenteric artery. clinical appearance of NOMI presents a myriad of symptoms and can be confusing, or might even be completely masked. In addition, there is still a lack of highly sensitive and specific biomarkers to predict the NOMI.
Furthermore, patients with postoperative NOMI had significantly high coincidence for acute kidney injury (AKI). NOMI has also been shown to correlate with renal insufficiency. Metzger et al. hypothesised that similar Pathophysiological mechanisms may trigger AKI in association with NOMI.
The aim of the study is to prospectively evaluate the level of perioperatively assessed I-FABP tests for NOMI and to correlate those with clinical or angiographic findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMI vs. non-AMI | – | Other: observational studyAMI, those with a acute mesenteric ischemia vs. non-AMI, those without a condition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing cardiac or vascular surgery with extracorporeal circulation in University Hospital Giessen
Key inclusion criteria (1 listed)
- All consecutive patients undergoing cardiac or vascular surgery with extracorporeal circulation
Key exclusion criteria (3 listed)
- endocarditis or bacterial sepsis,
- hepatitis or HIV on the patient\'s medical history,
- cases in which informed consent to participate in the study could not be obtained
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 |
|---|---|---|
| observational studyno intervention of interest | Other | AMI vs. non-AMI |
Primary outcome
Concentration of I-FABP values with/and without acute mesenteric ischemia
Time frame: 24 hours before and 36 hours after surgery
Is the variation of I-FABP values different in patients with and without the mesenteric ischemia at the time of initial clinical suspicion?
4 secondary outcomes
Time interval to mesenteric ischemia
Time frame: 24 hours before until day 7 post-surgery
Overall mortality rate
Time frame: until day 30 post-surgery
Correlation of I-FABP with biomarkers of acute kidney injury
Time frame: 24 hours before until day 7 post-surgery
Association of mesenteric ischemia with hypercoagulable states
Time frame: 24 hours before until day 7 post-surgery
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 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Surgery With Cardiopulmonary Bypass and Acute Mesenteric Ischemia, run by University of Giessen 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 1 inclusion and 3 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 11 Apr 2025. 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?
Concentration of I-FABP values with/and without acute mesenteric ischemia (time frame: 24 hours before and 36 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.