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
Recruitment status was Recruiting
Sponsor:
Asan Medical Center
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
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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:
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
35 ≤ BT ≤ 38 ℃
- RR ≤ 35/min
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
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 May 16, 2013