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The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp

Sponsor
Universitas Airlangga (Other)
Overall Status
Recruiting
CT.gov ID
NCT05205304
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Abdominal aortic temporary cross clamping procedures in patients with placenta accreta undergoing hysterectomy have been performed at Dr. Soetomo Hospital Surabaya for a period of 4 years. In the aortic cross-clamping procedure, an ischemic condition occurs, after the cross-clamp is released the distal tissue from the occlusion which was initially in an ischemic state gets blood flow suddenly (reperfusion) causing Ischemia Reperfusion Injury. This study aims to determine the effect of transdermal administration of carbon dioxide (CO2) as a protective factor for ischemia reperfusion injury in patients undergoing Abdominal Aorta Temporary Cross Clamp. The design of this study is experimental in patients who underwent Abdominal Aorta Temporary Cross Clamp. Subjects were divided into two groups. The first group was treated with CO2 transdermal administration and the second group was the control group.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be divided into two groups. The first group is treated with CO2 transdermal administration and the second group is the control group.Subjects will be divided into two groups. The first group is treated with CO2 transdermal administration and the second group is the control group.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Subjects will be treated with liquid carbon dioxide (D'oxyva) administered transdermally on the thumb after the Aortic Cross Clamp is removed

Drug: D'Oxyva
The transdermal CO2 was administered via non-invasive vaporization technique accommodated by deoxyhemoglobin vasodilator (D'Oxyva)
Other Names:
  • Transdermal CO2

    		•
    No Intervention: Control group

    Subject will not be treated with liquid carbon dioxide (D'oxyva)

    Outcome Measures

    Primary Outcome Measures

    1. Malondyaldehyde [Basal, 1 hour after aortic cross clamp off]

      The malondyaldehyde concentration of the patient's serum measured by ELISA test method

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with Placenta Accreta diagnosed with placental accreta index (PAI) based on the results of ultrasound and underwent Abdominal Aorta Clamping Surgery (Control of Bleeding in Accreta)
    Exclusion Criteria:

    • Patients with severe comorbid disorders based on previous clinical examination: chronic kidney disease, heart disease

    • Patients with septic shock and sepsis

    • Patients with peripheral artery disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hari Daswin Pagehgiri Surabaya Bali Indonesia 80116

    Sponsors and Collaborators

    • Universitas Airlangga

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hari Daswin Pagehgiri, Resident of Thoracic, Cardiac, and Vascular Surgery Department, Universitas Airlangga
    ClinicalTrials.gov Identifier:
    NCT05205304
    Other Study ID Numbers:
    • TCVS UA
    First Posted:
    Jan 25, 2022
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Hari Daswin Pagehgiri, Resident of Thoracic, Cardiac, and Vascular Surgery Department, Universitas Airlangga
    Abdominal Aortic Cross Clamp
    Additional relevant MeSH terms:
    Placenta Accreta

    Study Results

    No Results Posted as of Apr 5, 2022