Acetazolamide Facilitates Ventilator Weaning

NCT ID: NCT01131377

Last Updated: 2010-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Ventilator Weaning; Alkalosis, Metabolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

acetazolamide

Intervention Type: DRUG

If ABGA is pH ≥ 7.43 & HCO3- ≥ 26mEq/L at 7am, they will receive acetazolamide 500mg via IV q 24h.

If ABGA is pH ≤ 7.35 at 7am, acetazolamide will skip.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

They will receive saline 50ml via IV q 24h.

Interventions

acetazolamide

If ABGA is pH ≥ 7.43 & HCO3- ≥ 26mEq/L at 7am, they will receive acetazolamide 500mg via IV q 24h.

If ABGA is pH ≤ 7.35 at 7am, acetazolamide will skip.

Intervention Type: DRUG

Saline

They will receive saline 50ml via IV q 24h.

Intervention Type: DRUG

Other Intervention Names

acetazolamide = Zoladin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Principal Investigators

Chae-Man Lim, professor

Role: STUDY_CHAIR

Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Locations

AMC MICU; Asan medical center

Seoul, 388-1, Pungnap-dong, Songpa-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Eun Young Choi, Fellow

Role: CONTACT

letact@hanmail.net

+82-2-3010-3894

Chae-Man Lim, professor

Role: CONTACT

cmlim@amc.seoul.kr

+82-2-3010-3135

Facility Contacts

Chae-Man Lim, professor

Role: primary

cmlim@amc.seoul.kr

+82-2-3010-3135

Eun Young Choi, fellow

Role: backup

letact@hanmail.net

+82-2-3010-3894

Other Identifiers

AMCAZM-150

Identifier Type: -

Identifier Source: org_study_id