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

Ischemia Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397732
• Other study ID #: 4330
• Status: Completed
• Phase: N/A
• First received: January 6, 2018
• Last updated: January 11, 2018
• Start date: January 1, 2012
• Est. completion date: June 1, 2013

Study information

• Verified date: January 2018
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2013
• Est. primary completion date: June 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

Procedure:
• aorto-bifemoral bypass and aorta stentgraft
Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

References & Publications (2)

Mühl D, Nagy B, Woth G, Falusi B, Bogár 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. — View Citation

Nagy B, Szélig L, Rendeki S, Loibl C, Rézmán B, Lantos J, Bogár 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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