The Role of SCUBE-1 in Ischemia-reperfusion Injury

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Gonarthrosis
• Intervention / Treatment: Diagnostic test: spinal anesthesia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • university of health siences diskapi yildirim beyazit T&R hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the patients who will go to surgery for gonarthrosis disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
diabetic; the patients must have diabetic disease	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
control; the patients must not have diabetic	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCUBE-1	mean level of SCUBE-1	before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
malondialdehyde (MDA)	mean level of MDA	before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation
total antioxidant capacity	mean level of total antioxidant capacity (TAC)	before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2018
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (ACTUAL): January 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: SCUBE-1
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Ischemia; Osteoarthritis, Knee; Reperfusion Injury; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: scube1

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