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

Phase 4

• Conditions: Placenta Accreta
• Interventions: Drug: D'Oxyva

• Registration Number: NCT05205304
• Lead Sponsor: Universitas Airlangga

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-01-25
• Study Start: 2022-03-01
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-05
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Malondyaldehyde	Basal, 1 hour after aortic cross clamp off	The malondyaldehyde concentration of the patient's serum measured by ELISA test method

Trial Locations

Locations (1)

Hari Daswin Pagehgiri; 🇮🇩 Surabaya, Bali, Indonesia