Intestinal fatty acid-binding protein (I-FAB) for the early diagnosis of acute mesenteric ischemia

Recruiting

• Conditions: K55.0; Acute vascular disorders of intestine

• Registration Number: DRKS00034088
• Lead Sponsor: niversitätsklinikum Dresden, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with subsequent elective surgery can be included in the study:
- open thoracoabdominal aortic replacement
- aortic replacement with suprarenal clamping
- complex endovascular aortic repair with stenting of visceral vessels
- complicated type B aortic dissections.
Over a period of 24 months, all patients with unspecific or specific symptoms of acute mesenteric ischemia (AMI) will be examined for three inclusion criteria for the study in addition to the above-mentioned patients:
(1) Clinical: Urgent clinical suspicion of AMI, e.g. acute abdomen with sudden onset of pain, history of angina abdominalis, severe intestinal patency disorder with increasing or persistent need for vasopressors
(2) Serological: lactatemia with an initial increase above 2.5 mmol/l or persistent values above 5.0 mmol/l over 12 hours postoperatively
(3) Instrumental: Endoscopic evidence (ischemic mucosa, transmural necrosis) or computed tomography evidence (pneumatosis intestinalis, occlusion of visceral vessels). In addition, intraoperative measurement of intestinal blood flow using indocyanine green (ICG) in suspected cases of reduced blood flow.

Exclusion Criteria

- pregnancy
- lack of written consent from the patient or their legal representative within 96 hours of study inclusion (preoperatively)
- patients who are unable to participate in the study due to lack of compliance or language skills

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the correlation of the I-FABP level in serum with the manifest visceral malperfusion with bowel requiring resection. <br>I-FABP measurement points: immediately after study inclusion (i.e. at the time of suspected AMI or preoperatively, T0), immediately postoperatively (after transfer from the OR to the ward, T1) and 6h (T2), 12h (T3), 24h (T4) and 48h (T5) after study inclusion. <br>Methods: blood serum collection and ELISA test, intraoperative documentation with CRF

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints of this study are defined as:<br>- Sensitivity and specificity of I-FABP<br>- Differences in the diagnostic value of I-FAB in serum and urine<br>- Correlation of I-FAB with other ischemia markers (L-lactate, ICG measurements)<br>- Perioperative mortality and morbidity up to the time of discharge<br>- Length of stay at hospital and at IC