Acetazolamide Facilitates Ventilator Weaning

Not Applicable

• Conditions: Ventilator Weaning; Alkalosis, Metabolic
• Interventions: Drug: acetazolamide; Drug: Saline

• Registration Number: NCT01131377
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study Start: 2010-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Last Update Submitted: 2010-05-26
• Study First Posted: 2010-05-27
• Last Update Posted: 2010-05-27
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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:

  1. Oxygenation

     • FiO2 ≤ 0.4 & PaO2 ≥ 60 mmHg

       • O2 index (PaO2/FiO2) ≥ 150

         • SaO2 > 90%

           • PEEP ≤ 5 cmH2O

             • MN ≤ 15 L/min

  2. Vital sign

     • 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

  3. 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetazolamide	acetazolamide	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.
Placebo	Saline	This group will be managed with general metabolic alkalosis treatment such as electrolyte correction, hydration except acetazolamide.

Primary Outcome Measures

Name	Time	Method
weaning time between two group	hour	Weaning time : \[total ventilation time\] - \[total controlled mode time\]

Secondary Outcome Measures

Name	Time	Method
Successful weaning rate between two group		Successful weaning : self respiration more than 48h after withdrawl mechanical ventilation
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

Trial Locations

Locations (1)

AMC MICU; Asan medical center; 🇰🇷 Seoul, 388-1, Pungnap-dong, Songpa-gu, Korea, Republic of