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The Role of SCUBE-1 in Ischemia-reperfusion Injury

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ClinicalTrials.gov Identifier: NCT03389607
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

Brief 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


Condition or disease Intervention/treatment
Gonarthrosis Diabetes 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.


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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of SCUBE-1 in Ischemia-reperfusion Injury in Patients With Knee Prosthesis
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : February 1, 2019

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




Primary Outcome Measures :
  1. SCUBE-1 [ Time Frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation ]
    mean level of SCUBE-1


Secondary Outcome Measures :
  1. malondialdehyde (MDA) [ Time Frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation ]
    mean level of MDA

  2. total antioxidant capacity [ Time Frame: before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation ]
    mean level of total antioxidant capacity (TAC)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-70
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the patients who will go to surgery for gonarthrosis disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389607


Locations
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Turkey
university of health siences diskapi yildirim beyazit T&R hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital

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Responsible Party: Savas Altinsoy, principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03389607     History of Changes
Other Study ID Numbers: scube1
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital:
SCUBE-1
Additional relevant MeSH terms:
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Reperfusion Injury
Ischemia
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs