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

Placenta Accreta Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205304
• Other study ID #: TCVS UA
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Universitas Airlangga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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

Locations

Country	Name	City	State
Indonesia	Hari Daswin Pagehgiri	Surabaya	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Airlangga

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malondyaldehyde	The malondyaldehyde concentration of the patient's serum measured by ELISA test method	Basal, 1 hour after aortic cross clamp off