N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.
Słowa kluczowe
Abstrakcyjny
Opis
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.
Daktyle
| Ostatnia weryfikacja: | 08/31/2019 |
| Pierwsze przesłane: | 08/15/2019 |
| Szacowana liczba przesłanych rejestracji: | 09/03/2019 |
| Wysłany pierwszy: | 09/05/2019 |
| Ostatnia aktualizacja przesłana: | 09/04/2019 |
| Ostatnia opublikowana aktualizacja: | 09/08/2019 |
| Rzeczywista data rozpoczęcia badania: | 05/20/2019 |
| Szacowana data zakończenia podstawowej działalności: | 05/20/2023 |
| Szacowana data zakończenia badania: | 05/20/2023 |
Stan lub choroba
Interwencja / leczenie
Drug: N-acetyl Cysteine
Drug: Placebo
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: N-acetyl Cysteine 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. | Drug: N-acetyl Cysteine 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 pulmonary endarterectomy or balloon pulmonary angioplasty. |
| Placebo Comparator: Placebo 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 | Drug: Placebo The placebo group will receive a similar volume of normal saline as a placebo at the same time intervals. |
Kryteria kwalifikacji
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - Patients who are diagnosed with group 4 pulmonary hypertension and are susceptible to pulmonary endarterectomy or balloon angioplasty in patients over 18 years. Exclusion Criteria: - Patients who do not accept admission to the trial. - Presence of arterial hypotension or sepsis. |
Wynik
Podstawowe miary wyników
1. Presence of Post-reperfusion pulmonary injury. [72 hours]
Miary wyników wtórnych
1. Concentration of cytokines (pg/ml) [Basal and at 72 hours]
2. Percentaje of Complications (%) [30 days]
