Clinical trial NCT01131377: Acetazolamide Facilitates Ventilator Weaning
Official title: Acetazolamide Facilitates Ventilator Weaning Multicenter, Prospective, Double Blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilator Weaning
Alkalosis, Metabolic
Keywords: mechanical ventilation weaning phase patients with metabolic alkalosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: weaning time between two group
timeFrame: hour
Secondary outcomes:
measure: Successful weaning rate between two group
measure: total duration of mechanical ventilation between two group
timeFrame: hour
measure: length of ICU stay between two group
timeFrame: hour
measure: frequency of ventilator associated pneumonia between two group
measure: overall ICU mortality between two group
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AMC MICU; Asan medical center
state: 388-1, Pungnap-dong, Songpa-gu
Study officials:
affiliation: Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
name: Chae-Man Lim, professor
role: STUDY_CHAIR
References: