Acetazolamide Facilitates Ventilator Weaning

Asan Medical Center

Status: Unknown

Conditions: Ventilator Weaning; Alkalosis, Metabolic

Treatments: Drug: acetazolamide; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01131377

AMCAZM-150

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Acetazolamide

Experimental group

Description:

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.

Treatment:

Drug: acetazolamide

Placebo

Placebo Comparator group

Description:

This group will be managed with general metabolic alkalosis treatment such as electrolyte correction, hydration except acetazolamide.

Treatment:

Drug: Saline