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

U

Universitas Airlangga

Status and phase

Unknown
Phase 4

Conditions

Placenta Accreta

Treatments

Drug: D'Oxyva

Study type

Interventional

Funder types

Other

Identifiers

NCT05205304
TCVS UA

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Treatment group
Experimental group
Description:
Subjects will be treated with liquid carbon dioxide (D'oxyva) administered transdermally on the thumb after the Aortic Cross Clamp is removed
Treatment:
Drug: D'Oxyva
Control group
No Intervention group
Description:
Subject will not be treated with liquid carbon dioxide (D'oxyva)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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