Clinical trial NCT03397732: Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury
Official title: Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia Reperfusion Injury
Keywords: Matrix metalloproteinase
Tissue inhibitor of matrix metalloproteinase
Vascular surgery
Aorta stent implantation
Aorto-bifemoral bypass surgery
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed atherosclerotic and/or aorta aneurysma generaly associated with hypertension and diabetes

Brief summary: The MMP-9-TIMP-1 system has been implicated in many physiological and pathophysiological conditions including vascular surgery related ischemic-reperfusion injury. Our key aims were to establish the early perioperative time courses of the aforementioned system in aorto-bifemoral bypass and aorta stentgraft implantation procedures and to find correlation between the MMP-9-TIMP-1 system and the cross-clamp time. Patients were prospectively enrolled after Ethical Committee approval. Blood samples were taken at four different time points (T1-4): T1: right before surgery, T2: 60 min after the cross-clamp release, T3: first postoperative morning, T4: third postoperative morning. Plasma was isolated from heparin anticoagulated blood samples by low speed centrifugation at 4 °C, and stored at -80 °C until analyzed in a single batch at the end of the study. MMP- 9 and TIMP-1 were determined by the quantitative sandwich enzyme-linked immunosorbent assay (ELISA) techniques according to the manufacturer instructions (R\&D Systems Inc., Minneapolis, Minnesota, USA). In comparison with standard curves, the concentrations of MMP-9 and TIMP-1 in plasma were determined spectrophotometrically (Multiskan Ascent microplate photometer, Type: 354, Thermo Electron Corporation, Waltham, Massachusetts, USA) by reading the absorbance at 450 nm. Plasma concentrations of MMP-9 and TIMP-1 were expressed as ng/ml.


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective procedure (aorto-bifemoral bypass or aorta stentgraft implantation) by vascular surgeons.
* Over age 18
* agree to participate

Exclusion Criteria:

* under age 18
* refuse to participate
* diagnosed malignant disease
* chronic steroid usage
* being on cytostatic therapy

Primary outcomes:
measure: Perioperative time course of the MMP-9-TIMP-1 system
timeFrame: 3 days
Secondary outcomes:
measure: MMP-9-TIMP-1 system and ischemia-reperfusion injury
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Pécs, Dept. of Anaesthesia and Intensive Care Pécs, Baranya county, Hungary
name: Diána Mühl, MD, PhD
role: STUDY_CHAIR
References:
citation: Nagy B, Szelig L, Rendeki S, Loibl C, Rezman B, Lantos J, Bogar L, Csontos C. Dynamic changes of matrix metalloproteinase 9 and tissue inhibitor of metalloproteinase 1 after burn injury. J Crit Care. 2015 Feb;30(1):162-6. doi: 10.1016/j.jcrc.2014.07.008. Epub 2014 Jul 11.
citation: Muhl D, Nagy B, Woth G, Falusi B, Bogar L, Weber G, Lantos J. Dynamic changes of matrix metalloproteinases and their tissue inhibitors in severe sepsis. J Crit Care. 2011 Dec;26(6):550-5. doi: 10.1016/j.jcrc.2011.02.011. Epub 2011 May 6.