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Acetazolamide Facilitates Ventilator Weaning

Primary Purpose

Ventilator Weaning, Alkalosis, Metabolic

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

acetazolamide

Saline

About this trial

This is an interventional treatment trial for Ventilator Weaning focused on measuring mechanical ventilation weaning phase patients with metabolic alkalosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AMC MICU; Asan medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

weaning time between two group

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

Secondary Outcome Measures

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

length of ICU stay between two group

frequency of ventilator associated pneumonia between two group

overall ICU mortality between two group

Full Information

NCT ID

NCT01131377

First Posted

May 26, 2010

Last Updated

May 26, 2010

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01131377

Brief Title

Acetazolamide Facilitates Ventilator Weaning

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2011 (Anticipated)

Study Completion Date

May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asan Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventilator Weaning, Alkalosis, Metabolic

Keywords

mechanical ventilation weaning phase patients with metabolic alkalosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acetazolamide

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

acetazolamide

Other Intervention Name(s)

acetazolamide = Zoladin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

weaning time between two group

Description

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

Time Frame

hour

Secondary Outcome Measure Information:

Title

Successful weaning rate between two group

Description

Successful weaning : self respiration more than 48h after withdrawl mechanical ventilation

Title

total duration of mechanical ventilation between two group

Time Frame

hour

Title

length of ICU stay between two group

Time Frame

hour

Title

frequency of ventilator associated pneumonia between two group

Title

overall ICU mortality between two group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eun Young Choi, Fellow

Phone

+82-2-3010-3894

letact@hanmail.net

First Name & Middle Initial & Last Name or Official Title & Degree

Chae-Man Lim, professor

Phone

+82-2-3010-3135

cmlim@amc.seoul.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chae-Man Lim, professor

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

AMC MICU; Asan medical center

City

Seoul

State/Province

388-1, Pungnap-dong, Songpa-gu

ZIP/Postal Code

138-736

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chae-Man Lim, professor

Phone

+82-2-3010-3135

cmlim@amc.seoul.kr

First Name & Middle Initial & Last Name & Degree

Eun Young Choi, fellow

Phone

+82-2-3010-3894

letact@hanmail.net

First Name & Middle Initial & Last Name & Degree

Eun Young Choi, fellow

12. IPD Sharing Statement

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Acetazolamide Facilitates Ventilator Weaning

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