NCT01131377Unknown不适用
Acetazolamide Facilitates Ventilator Weaning Multicenter, Prospective, Double Blinded, Randomised Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- weaning time between two group
研究概览
简要总结
Metabolic alkalosis(MA) is common metabolic disorder in ICU setting. MA could be cause of weaning failure or delay by depression of respiratory center. The purpose of this study is to evaluate that correction of MA by administration of acetazolamide facilitates weaning of mechanical ventilation.
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on mechanical ventilation for at least 24 hours with an assisted mode and passed acute resuscitation and considered for weaning. (Definition of Weaning point:
- •Oxygenation
- •FiO2 ≤ 0.4 & PaO2 ≥ 60 mmHg
- •O2 index (PaO2/FiO2) ≥ 150
- •SaO2 > 90%
- •PEEP ≤ 5 cmH2O
- •MN ≤ 15 L/min
- •Stable BP: MAP ≥ 60 mmHg ((i.e., no epinephrine or norepinephrine <0.2μg/kg/min, or equivalent dose vasopressin or phenylephrine)
- •HR ≤ 140bpm
- •35 ≤ BT ≤ 38 ℃
- •RR ≤ 35/min
- •Clinical status
- •resolution of acute disease process
- •no newly developed pulmonary infiltration
- •Ramsay sedation score 2~4
- •Hb > 7, pH > 7.30, normal electrolyte
- •no active bleeding, no IICP, no bronchospasm, no CAD
- •no rescure or specific treatment (NO, prone, OP plan)
- •ABGA : pH ≥ 7.43 and HCO3- ≥ 26mEq/L
排除标准
- •Permanent ventilator dependency due to brainstem disease, diffuse cerebral disease, severe respiratory or neuromuscular disease
- •Active bleeding, IICP, unstable coronary artery disease, bronchospasm, and rescue treatment (inhaled NO, prone), pre-op condition
- •Contraindication to acetazolamide: renal insufficiency (creatinine clearance <20 ml/min and/or renal replacement therapy), intolerance or allergy to acetazolamide or sulfonamides, hyperchloremic metabolic acidosis, hyponatremia (Na<130), hypokalemia (K<3.5), adrenal insufficiency.
- •Diaphragm dysfunction : as diagnosed by fluoroscopy, nerve conduction velocity, USG, or overt paradoxical motion of the abdomen
研究组 & 干预措施
Acetazolamide
Experimental
If ABGA is pH ≥ 7.43 & HCO3- ≥ 26mEq/L at 7am, they will receive acetazolamide 500mg via IV.
If ABGA is pH ≤ 7.35 at 7am, acetazolamide will skip.
干预措施: acetazolamide (Drug)
Placebo
Placebo Comparator
This group will be managed with general metabolic alkalosis treatment such as electrolyte correction, hydration except acetazolamide.
干预措施: Saline (Drug)
结局指标
主要结局
weaning time between two group
时间窗: hour
Weaning time : \[total ventilation time\] - \[total controlled mode time\]
次要结局
- Successful weaning rate between two group
- total duration of mechanical ventilation between two group(hour)
- length of ICU stay between two group(hour)
- frequency of ventilator associated pneumonia between two group
- overall ICU mortality between two group
研究者
研究点 (1)
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