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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03397732
Other study ID # 4330
Secondary ID
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
Health authority
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

Study Design


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
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