Acetazolamide Facilitates Ventilator Weaning

Ventilator Weaning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01131377
• Other study ID #: AMCAZM-150
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2010
• Last updated: May 26, 2010
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2010
• Source: Asan Medical Center
• Contact: Eun Young Choi, Fellow
• Phone: +82-2-3010-3894
• Email: letact[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alkalosis
• Alkalosis, Metabolic
• Ventilator Weaning

Intervention

Drug:
• 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.
• Saline
They will receive saline 50ml via IV q 24h.

Locations

Country	Name	City	State
Korea, Republic of	AMC MICU; Asan medical center	Seoul	388-1, Pungnap-dong, Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weaning time between two group	Weaning time : [total ventilation time] - [total controlled mode time]	hour	No
Secondary	Successful weaning rate between two group	Successful weaning : self respiration more than 48h after withdrawl mechanical ventilation		No
Secondary	total duration of mechanical ventilation between two group		hour	No
Secondary	length of ICU stay between two group		hour	No
Secondary	frequency of ventilator associated pneumonia between two group			Yes
Secondary	overall ICU mortality between two group			Yes