Effects of Acetazolamide on the Duration of Mechanical Ventilation in Patients With Metabolic Alkalosis. Phase III Multicenter Double-blinded Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 8
- 主要终点
- Length of mechanical ventilation
研究概览
简要总结
The purpose of this study is to analyze whether the treatment of metabolic alkalosis with acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or with obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation (MV).
详细描述
Metabolic alkalosis (MA) may reduce central respiratory drive, cardiac output and worsen oxygenation, leading to a delay in weaning from MV. Acetazolamide is a carbonic anhydrase inhibitor that is able to correct MA and to stimulate respiratory drive. There is a paucity of studies on the outcome of patients with MA under MV treated with acetazolamide.
The primary objective of our study is to analyze whether the treatment of MA with acetazolamide in intubated patients with COPD or with OHS reduces the length of MV, reduces the length of ICU stay or ICU mortality. Complications associated with acetazolamide treatment will be also analyzed.
Phase III double-blinded trial, with COPD or OHS patients under MV who have pH > 7,35 and bicarbonate > 28 mEq/L. Patients will be randomized to receive 500 mg of acetazolamide or placebo. According to arterial blood gas analysis (ABGA) values treatment administration will be evaluated daily until extubation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD or obesity hypoventilation syndrome on invasive mechanical ventilation during less than 72 h with metabolic alkalosis, defined as a pH > 7.35 and actual bicarbonate > 28 mmol/L, and with potassium plasmatic levels >= 4 mEq/L.
排除标准
- •Postoperative patients.
- •Previous psychiatric disease.
- •Epilepsy.
- •Pregnancy.
- •Hepatic cirrhosis.
- •Sulfonamide or acetazolamide allergy.
- •Plasmatic creatinine > 2.5 mg/dL or creatinine clearance < 20 mL/min or continuous renal replacement techniques.
- •Intolerance to enteral feeding.
- •Administration in the previous 72 h of bicarbonate or acetazolamide.
- •Terminal disease.
研究组 & 干预措施
Acetazolamide
干预措施: Acetazolamide (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Length of mechanical ventilation
时间窗: From intubation date to extubation date, an expected average of 1 week
次要结局
- Length of intensive care unit stay(The duration of ICU stay, an expected average less than 2 weeks)
- All cause hospital mortality(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
- Complications associated to the treatment(During the mechanical ventilation period, an expected average of 1 week)
研究者
Gemma Rialp
MD; PhD
Hospital Son Llatzer