Acetazolamide Facilitates Ventilator Weaning

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01131377
First received: May 26, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Ventilator Weaning
Alkalosis, Metabolic
Drug: acetazolamide
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Acetazolamide Facilitates Ventilator Weaning Multicenter, Prospective, Double Blinded, Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • weaning time between two group [ Time Frame: hour ] [ Designated as safety issue: No ]
    Weaning time : [total ventilation time] - [total controlled mode time]


Secondary Outcome Measures:
  • Successful weaning rate between two group [ Designated as safety issue: No ]
    Successful weaning : self respiration more than 48h after withdrawl mechanical ventilation

  • total duration of mechanical ventilation between two group [ Time Frame: hour ] [ Designated as safety issue: No ]
  • length of ICU stay between two group [ Time Frame: hour ] [ Designated as safety issue: No ]
  • frequency of ventilator associated pneumonia between two group [ Designated as safety issue: Yes ]
  • overall ICU mortality between two group [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

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.

Other Name: acetazolamide = Zoladin
Placebo Comparator: Placebo
This group will be managed with general metabolic alkalosis treatment such as electrolyte correction, hydration except acetazolamide.
Drug: Saline
They will receive saline 50ml via IV q 24h.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131377

Contacts
Contact: Eun Young Choi, Fellow +82-2-3010-3894 letact@hanmail.net
Contact: Chae-Man Lim, professor +82-2-3010-3135 cmlim@amc.seoul.kr

Locations
Korea, Republic of
AMC MICU; Asan medical center Recruiting
Seoul, 388-1, Pungnap-dong, Songpa-gu, Korea, Republic of, 138-736
Contact: Chae-Man Lim, professor    +82-2-3010-3135    cmlim@amc.seoul.kr   
Contact: Eun Young Choi, fellow    +82-2-3010-3894    letact@hanmail.net   
Principal Investigator: Eun Young Choi, fellow         
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: Chae-Man Lim, professor Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Chae-Man Lim/Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
ClinicalTrials.gov Identifier: NCT01131377     History of Changes
Other Study ID Numbers: AMCAZM-150
Study First Received: May 26, 2010
Last Updated: May 26, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
mechanical ventilation weaning phase patients with metabolic alkalosis

Additional relevant MeSH terms:
Alkalosis
Acid-Base Imbalance
Metabolic Diseases
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 28, 2014