Acetazolamide Facilitates Ventilator Weaning

NCT01131377 | Unknown

• 1 other identifier: AMCAZM-150
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

mechanical ventilation weaning phase patients with metabolic alkalosis

Outcome Measures

Primary Outcomes (1)

• weaning time between two group

  Weaning time : \[total ventilation time\] - \[total controlled mode time\]

  hour

Secondary Outcomes (5)

• Successful weaning rate between two group

• 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

Study Arms (2)

Acetazolamide

EXPERIMENTAL

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.

Drug: acetazolamide

Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

acetazolamide 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.

Also known as: acetazolamide = Zoladin

Acetazolamide

Saline DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Oxygenation
• FiO2 ≤ 0.4 \& PaO2 ≥ 60 mmHg
• O2 index (PaO2/FiO2) ≥ 150
• SaO2 \> 90%
• PEEP ≤ 5 cmH2O
• MN ≤ 15 L/min
• 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
• ≤ BT ≤ 38 ℃
• RR ≤ 35/min
• Clinical status
• resolution of acute disease process
• no newly developed pulmonary infiltration

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

AMC MICU; Asan medical center

Seoul, 388-1, Pungnap-dong, Songpa-gu, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Alkalosis

Interventions

Acetazolamide; Sodium Chloride

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chae-Man Lim, professor

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

  STUDY CHAIR

Central Study Contacts

Eun Young Choi, Fellow

CONTACT

+82-2-3010-3894; letact@hanmail.net

Chae-Man Lim, professor

CONTACT

+82-2-3010-3135; cmlim@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 27, 2010

Record last verified: 2010-04

Locations

KR (1)