Perioperative Evaluation of MMP-9-TIMP-1 System in Vascular Surgery Regarding Ischemic-reperfusion Injury

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.

Study Overview

• Status: Completed
• Conditions: Ischemia Reperfusion Injury
• Intervention / Treatment: Procedure: aorto-bifemoral bypass and aorta stentgraft

• Study Type: Observational
• Enrollment (Actual): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnosed atherosclerotic and/or aorta aneurysma generaly associated with hypertension and diabetes

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aorto-bifemoral bypass; Patients scheduled for elective aorto-bifemoral bypass surgery by vascular surgeons and consented to participate in the study.	Procedure: aorto-bifemoral bypass and aorta stentgraft; Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.
Aorta stentgraft; Patients scheduled for elective aorta stentgraft implantation by vascular surgeons and consented to participate in the study.	Procedure: aorto-bifemoral bypass and aorta stentgraft; Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative time course of the MMP-9-TIMP-1 system	To establish the early perioperative time course of MMP-9-TIMP-1 system in aorto-bifemoral bypass and aorta stentgraft implantation.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMP-9-TIMP-1 system and ischemia-reperfusion injury	To explore relationship between MMP-9-TIMP-1 system and vascular surgery related ischemia-reperfusion injury	3 days

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Study Chair: Diána Mühl, MD, PhD, University of Pécs, Dept. of Anaesthesia and Intensive Care Pécs, Baranya county, Hungary

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 6, 2018
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Matrix metalloproteinase; Vascular surgery; Tissue inhibitor of matrix metalloproteinase; Aorta stent implantation; Aorto-bifemoral bypass surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Wounds and Injuries; Reperfusion Injury
• Other Study ID Numbers: 4330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No