The Role of SCUBE-1 in Ischemia-reperfusion Injury

Diabetes Clinical Trial

Official title:

The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389607
• Other study ID #: scube1
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2019
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury. Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4 hours.

SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells, including endothelium and platelets. Immunohistochemical demonstration of subendothelial matrix deposition in atherosclerosis in humans. We did not find any study that showed the post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic events in the literature.

in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced by tourniquet application in knee prosthesis attempts in our aimed patients and compare this with other total antioxidant status (TAS) and MDA of ischemia-reperfusion parameters

Description:

After being taken to the operation room, the patient will be divided into two groups as group D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure measurements.

In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22 gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1 min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in both groups. The disease tourniquet will be applied after induction, in accordance with the literature, to be above 150 mmHg of the systolic blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus

• knee replacement surgery

• using a pneumatic tourniquet

Exclusion Criteria:

• coronary artery disease

• renal disorders

• cognitive disorders

• bleeding diathesis

• who have passed general anesthesia

• anti-inflammatory drugs treatment

• abnormal HbA1c values

Related Conditions & MeSH terms

• Diabetes
• Gonarthrosis
• Ischemia
• Reperfusion Injury

Intervention

Diagnostic Test:
• spinal anesthesia
before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma

Locations

Country	Name	City	State
Turkey	university of health siences diskapi yildirim beyazit T&R hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCUBE-1	mean level of SCUBE-1	before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Secondary	malondialdehyde (MDA)	mean level of MDA	before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
Secondary	total antioxidant capacity	mean level of total antioxidant capacity (TAC)	before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation