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Acetazolamide Facilitates Ventilator Weaning

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ventilator Weaning; Alkalosis, Metabolic

Intervention: acetazolamide (Drug); Saline (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Chae-Man Lim, professor, Study Chair, Affiliation: Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Overall contact:
Eun Young Choi, Fellow, Phone: +82-2-3010-3894, Email: letact@hanmail.net

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.

Clinical Details

Official title: Acetazolamide Facilitates Ventilator Weaning Multicenter, Prospective, Double Blinded, Randomised Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: weaning time between two group

Secondary outcome:

Successful weaning rate between two group

total duration of mechanical ventilation between two group

length of ICU stay between two group

frequency of ventilator associated pneumonia between two group

overall ICU mortality between two group

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Eun Young Choi, Fellow, Phone: +82-2-3010-3894, Email: letact@hanmail.net

AMC MICU; Asan medical center, Seoul, 388-1, Pungnap-dong, Songpa-gu 138-736, Korea, Republic of; Recruiting
Chae-Man Lim, professor, Phone: +82-2-3010-3135, Email: cmlim@amc.seoul.kr
Eun Young Choi, fellow, Phone: +82-2-3010-3894, Email: letact@hanmail.net
Eun Young Choi, fellow, Principal Investigator
Additional Information

Starting date: May 2010
Last updated: May 26, 2010

Page last updated: November 27, 2014

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