K55.0
Conditions
Interventions
Group 1: Group 1, Ischemia: Clinically or histologically confirmed findings of ischemic damage to the bowel during a laparotomy
Group 2: Group 2, no ischemia: without clinical or histologic confirmati
Sponsors
Universitätsklinikum Dresden, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. Methods: blood serum collection and ELISA test, intraoperative documentation with CRF | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are defined as: - Sensitivity and specificity of I-FABP - Differences in the diagnostic value of I-FAB in serum and urine - Correlation of I-FAB with other ischemia markers (L-lactate, ICG measurements) - Perioperative mortality and morbidity up to the time of discharge - Length of stay at hospital and at ICU | — |
Countries
Germany
Contacts
Public ContactMarvin Kapalla
Universitätsklinikum Dresden Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie, Bereich Gefäßchirurgie
Outcome results
None listed