Ventilator WeaningNCT01131377
Acetazolamide Facilitates Ventilator Weaning
A study testing acetazolamide and Saline in people with Ventilator Weaning and Alkalosis, Metabolic, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Weaning, Alkalosis, Metabolic
- What is being tested?
- acetazolamide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
AMC MICU; Asan medical center
Seoul, 388-1, Pungnap-dong, Songpa-gu, 138-736
Chae-Man Lim, professor, +82-2-3010-3135, cmlim@amc.seoul.kr
Eun Young Choi, fellow, +82-2-3010-3894, letact@hanmail.net
About this study
Official title: Acetazolamide Facilitates Ventilator Weaning Multicenter, Prospective, Double Blinded, Randomised Controlled Trial
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
- Being tested
- acetazolamide, Saline
- Keywords
- mechanical ventilation weaning phase patients with metabolic alkalosis
- Medical subject headings
- Alkalosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
Also called acetazolamide = Zoladin
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.
SalineDrug
They will receive saline 50ml via IV q 24h.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: acetazolamide |
| Placebo | Placebo comparator | This group will be managed with general metabolic alkalosis treatment such as electrolyte correction, hydration except acetazolamide. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning time between two group
Weaning time : [total ventilation time] - [total controlled mode time]
Measured: hour
Secondary outcomes (5)
Successful weaning rate between two group
Successful weaning : self respiration more than 48h after withdrawl mechanical ventilation
total duration of mechanical ventilation between two group
Measured: hour
length of ICU stay between two group
Measured: hour
frequency of ventilator associated pneumonia between two group
overall ICU mortality between two group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Chae-Man Lim, professor, Study chair, Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131377
- Sponsor's protocol ID
- AMCAZM-150
- Status last verified
- Apr 2010
- First submitted
- 26 May 2010
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide Facilitates Ventilator Weaning Multicenter, Prospective, Double Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01131377
- Acronym / sponsor ID
- AMCAZM-150
- Conditions
- Ventilator Weaning, Alkalosis, Metabolic
- Keywords
- mechanical ventilation weaning phase patients with metabolic alkalosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: acetazolamideIf 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. |
| Placebo | Placebo comparator | Drug: SalineThis group will be managed with general metabolic alkalosis treatment such as electrolyte correction, hydration except acetazolamide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- ABGA : pH ≥ 7.43 and HCO3- ≥ 26mEq/L
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetazolamideAlso: acetazolamide = ZoladinIf 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. | Drug | Acetazolamide |
| SalineThey will receive saline 50ml via IV q 24h. | Drug | Placebo |
Primary outcome
weaning time between two group
Time frame: hour
Weaning time : [total ventilation time] - [total controlled mode time]
5 secondary outcomes
Successful weaning rate between two group
total duration of mechanical ventilation between two group
Time frame: hour
length of ICU stay between two group
Time frame: hour
frequency of ventilator associated pneumonia between two group
overall ICU mortality between two group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
Related trials for Ventilator Weaning
Not yet recruitingObservational study
Diaphragm Ultrasound and Rapid Shallow Breathing Index for Predicting Extubation Success
Ventilator Weaning, Respiratory Insufficiency
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Enrolling by invitation
Weighted Blanket to Improve Sedation and Comfort During Ventilator Weaning
Ventilated Patient in Intensive Care
Not yet recruitingObservational study
Comparison of Sarcopenia Index, Diaphragm Ultrasonography, and Traditional Weaning Parameters in Predicting Successful Weaning From Mechanical Ventilation
Ventilator Weaning, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chae-Man Lim, professor study chair
Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetazolamide and Saline in people with Ventilator Weaning and Alkalosis, Metabolic, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Young Choi, Fellow (+82-2-3010-3894, letact@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning time between two group (time frame: hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.