Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI)

NCT06365827 | Completed DMC

• 1 other identifier: AZ293/20
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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?

  24 hours before and 36 hours after surgery

Secondary Outcomes (4)

• Time interval to mesenteric ischemia

  24 hours before until day 7 post-surgery

• Overall mortality rate

  until day 30 post-surgery

• Correlation of I-FABP with biomarkers of acute kidney injury

  24 hours before until day 7 post-surgery

• Association of mesenteric ischemia with hypercoagulable states

  24 hours before until day 7 post-surgery

Other Outcomes (2)

• Incidence of stroke

  until day 30 post-surgery

• Association of I-FABP level and multi-organ failure or cardiovascular mortality

  until day 30 post surgery

Study Arms (1)

AMI vs. non-AMI

AMI, those with a acute mesenteric ischemia vs. non-AMI, those without a condition

Other: observational study

Interventions

observational study OTHER

no intervention of interest

AMI vs. non-AMI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients undergoing cardiac or vascular surgery with extracorporeal circulation in University Hospital Giessen

You may qualify if:

• All consecutive patients undergoing cardiac or vascular surgery with extracorporeal circulation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Giessen, Cardiovascular surgery

Giessen, Hesse, 35392, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (serum and citrate) aliquots Urine aliquots

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: March 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

DE (1)