Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365827
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-09
Brief Title:
Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury Followed by Extracorporeal Circulation aMIKI
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
aMIKI
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None