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临床试验/NCT04081012
NCT04081012Unknown不适用

N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Balloon Angioplasty and Pulmonary Endarterectomy.

Instituto Nacional de Cardiologia Ignacio Chavez1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年5月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
1
主要终点
Presence of Post-reperfusion pulmonary injury.

研究概览

简要总结

This study will evaluate the use of N-acetyl cysteine in post-reperfusion pulmonary injury in patients with chronic thromboembolic pulmonary hypertension undergoing pulmonary balloon angioplasty and pulmonary endarterectomy. Half of the patients will receive N-acetyl cysteine and the other placebo.

详细描述

For chronic pulmonary embolism thrombus hypertension, the potentially curative treatment is endarterectomy, however in 12 to 60% it does not present surgical susceptibility, so pulmonary balloon angioplasty is the secondary option. In these procedures the complication that occurs most frequently is pulmonary oedema after reperfusion is a frequent complication (17.8-65%), appears between 24-72 hours after the intervention and the diagnosis is made in the presence of infiltrate interstitial in chest radiography or computed tomography of the chest. Initially it was believed that it was difficult due to the increase in perfusion of secondary flow in the territory due to pulmonary vascular dilation, it is now believed that microtraumatism is involved by the guides and balloon used, vascular dysfunction and cytokines and innate immunity and adaptive, complement activation, coagulation cascade activation, apoptosis pathway activation, endothelial dysfunction caused by reperfusion contribute to cell dysfunction.

The use of N-acetyl cysteine for its antioxidant properties, inflammatory response attenuator, reduction of reactive oxygen species (ROS) and that in addition to having already had to reduce the condition of decrease in post-reperfusion ischemia15,16 in other situations is a viable option in the treatment of acute post-reperfusion edema in patients sometimes a pulmonary endarterectomy and balloon pulmonary angioplasty.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

It will be through sealed, opaque and numbered envelopes sequentially. The assignment sequence will be done by the pharmacist, the principal investigator will recruit the patients. Researchers and site staff (with the exception of the investigating pharmacologist) will be blinded to the assigned treatment. There will be no circumstances to unmask and reveal the intervention.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who are diagnosed with group 4 pulmonary hypertension and are susceptible to pulmonary endarterectomy or balloon angioplasty in patients over 18 years.

排除标准

  • Patients who do not accept admission to the trial.
  • Presence of arterial hypotension or sepsis.

研究组 & 干预措施

N-acetyl Cysteine

Experimental

Patients will receive a 4-dose schedule of 600 mg diluted in 50 ml of 0.9% saline intravenously every 12 hours starting 24 hours before endarterectomy or balloon angioplasty.

干预措施: N-acetyl cysteine (Drug)

Placebo

Placebo Comparator

The placebo group will receive a similar volume of normal saline as a placebo at the same time intervals. All study medications will be prepared by the Pharmacology department, which is not involved in patient care; the name of the medication and dose of the original ampule will be erased and also an identification label will be placed with the name, registration number, bed number, date and will be indifferent for groups with the same type of ampoule, with the same type of labeling

干预措施: Placebo (Drug)

结局指标

主要结局

Presence of Post-reperfusion pulmonary injury.

时间窗: 72 hours

Chest tomography will be performed using 35 mA, 100 Kv and 6 mm cuts, then the simple thorax (low dose) holding the inspiration in the cephalocaudal direction with 80 mA, 100 Kv, a duration of 2.24 seconds, pitch of 1 and cuts 1 mm Multiplanar reconstructions with Kernel filters B26f, B50f and B70f for mediastinum and lung respectively, at 1 mm cuts. And anteroposterior chest radiographs will be obtained with the same equipment, at the beginning of the study and daily on days 1 to 3.

次要结局

  • Percentaje of Complications (%)(30 days)
  • Concentration of cytokines (pg/ml)(Basal and at 72 hours)

研究者

发起方
Instituto Nacional de Cardiologia Ignacio Chavez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Elena Soto, MsC and PhD

Clinical Research

Instituto Nacional de Cardiologia Ignacio Chavez

研究点 (1)

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