Back to resultsThe Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp
Primary Purpose
Placenta Accreta
Status
Recruiting
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
D'Oxyva
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta focused on measuring Abdominal Aortic Cross Clamp
Eligibility Criteria
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
Sites / Locations
- Hari Daswin PagehgiriRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
Subjects will be treated with liquid carbon dioxide (D'oxyva) administered transdermally on the thumb after the Aortic Cross Clamp is removed
Subject will not be treated with liquid carbon dioxide (D'oxyva)
Outcomes
Primary Outcome Measures
Malondyaldehyde
The malondyaldehyde concentration of the patient's serum measured by ELISA test method
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05205304
Brief Title
The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Airlangga
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
Keywords
Abdominal Aortic Cross Clamp
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Subjects will be treated with liquid carbon dioxide (D'oxyva) administered transdermally on the thumb after the Aortic Cross Clamp is removed
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subject will not be treated with liquid carbon dioxide (D'oxyva)
Intervention Type
Drug
Intervention Name(s)
D'Oxyva
Other Intervention Name(s)
Transdermal CO2
Intervention Description
The transdermal CO2 was administered via non-invasive vaporization technique accommodated by deoxyhemoglobin vasodilator (D'Oxyva)
Primary Outcome Measure Information:
Title
Malondyaldehyde
Description
The malondyaldehyde concentration of the patient's serum measured by ELISA test method
Time Frame
Basal, 1 hour after aortic cross clamp off
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hari Daswin Pagehgiri
City
Surabaya
State/Province
Bali
ZIP/Postal Code
80116
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hari D Pagehgiri, MD
Phone
081933118881
Email
hari.daswin.pagehgiri-2016@fk.unair.ac.id
12. IPD Sharing Statement
Learn more about this trial
The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp
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