Aminophylline in treatment of acute exacerbation of COPD : ACUTE study(Aminophylline in COPD- utility and Treatment effects)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
The main Objective of the study is to assess safety, tolerability and clinicaleffects of aminophylline infusion in treatment of acute exacerbation of COPD
.
We intend to screen all patients presenting to our respiratory ICU withlabelled COPD in an exacerbation ( as defined by GOLD) for inclusion into ourstudy for a period of 1 year from 15.7.2022 .All of these patients will be managed conventionally withstandard therapy for COPD by an independent group of treating physicians. Post72 hours, the patients will be reassessed and all patients fitting theinclusion criteria will be administered aminophylline .All patients beingadministered aminophylline will be subject to continuous ECG monitoring and 6hourly abg analysis in the 24 hour period of aminophylline administration. Atleastanother arterial blood gas analysis will be done at the end of 48 hours ofinitiation of aminophylline infusion. Dyspnoea as measured by the modified BORGscale will be evaluated by an independent respiratory therapist.
Aminophyllineis an old and inexpensive drug which is known for its pleotropic action andsynergism with inhaled bronchodilators. It has fallen into disfavour due to itspronounced adverse effects. We believe when administered to the right sub groupof patients the benefits far out weigh the risks, and it may prove a worthysalvage option for critically ill patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient of documented COPD as per GOLD guidelines, admitted with COPD exacerbation.
- •Persistent hypoxia with PF ratio<200 AND hypercarbia with pCO2>45 ±respiratory acidosis despite maximal standard therapy for COPD exacerbation 72 hours post hospitalisation.
排除标准
- •Known structural or physiological cardiac co morbidity -Any other systemic co morbidity that is known to worsen with aminophylline -Persistent Tachycardia(Heart rate>100/min) with or without rate limiting drugs, wherever indicated.
- •If patient is on any drug known to interact with aminophylline.
结局指标
主要结局
Length of hospital stay
时间窗: Length of hospital stay | Length of ICU stay | ABG changes in Oxygenation- | ABG changes in pCO2 levels | AT 24 AND 48 HOURS AFTER DRUG INITIATION
Length of ICU stay
时间窗: Length of hospital stay | Length of ICU stay | ABG changes in Oxygenation- | ABG changes in pCO2 levels | AT 24 AND 48 HOURS AFTER DRUG INITIATION
ABG changes in Oxygenation- PF
时间窗: Length of hospital stay | Length of ICU stay | ABG changes in Oxygenation- | ABG changes in pCO2 levels | AT 24 AND 48 HOURS AFTER DRUG INITIATION
ratio
时间窗: Length of hospital stay | Length of ICU stay | ABG changes in Oxygenation- | ABG changes in pCO2 levels | AT 24 AND 48 HOURS AFTER DRUG INITIATION
ABG changes in pCO2 levels
时间窗: Length of hospital stay | Length of ICU stay | ABG changes in Oxygenation- | ABG changes in pCO2 levels | AT 24 AND 48 HOURS AFTER DRUG INITIATION
次要结局
- 1.Dyspnoea: modified Borg Scale(2.Mortality)
