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临床试验/NCT05205304
NCT05205304Unknown4 期

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

Universitas Airlangga1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
30
试验地点
1
主要终点
Malondyaldehyde

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Treatment group

Experimental

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

干预措施: D'Oxyva (Drug)

结局指标

主要结局

Malondyaldehyde

时间窗: Basal, 1 hour after aortic cross clamp off

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hari Daswin Pagehgiri

Resident of Thoracic, Cardiac, and Vascular Surgery Department

Universitas Airlangga

研究点 (1)

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