Treatment of Metabolic Alkalosis With Acetazolamide. Effect on the Length of Mechanical Ventilation.

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT01499485
• Date of registration: 20/12/2011
• Prospective Registration: No
• Primary sponsor: Hospital Son Llatzer
• Public title: Treatment of Metabolic Alkalosis With Acetazolamide. Effect on the Length of Mechanical Ventilation. TRAMA
• Scientific title: Effects of Acetazolamide on the Duration of Mechanical Ventilation in Patients With Metabolic Alkalosis. Phase III Multicenter Double-blinded Clinical Trial.
• Date of first enrolment: November 2011
• Target sample size: 140
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01499485
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with COPD or obesity hypoventilation syndrome on invasive mechanical
ventilation during less than 72 h with metabolic alkalosis, defined as a pH > 7.35
and actual bicarbonate > 28 mmol/L, and with potassium plasmatic levels >= 4 mEq/L.

Exclusion Criteria:

- Postoperative patients.

- Previous psychiatric disease.

- Epilepsy.

- Pregnancy.

- Hepatic cirrhosis.

- Sulfonamide or acetazolamide allergy.

- Plasmatic creatinine > 2.5 mg/dL or creatinine clearance < 20 mL/min or continuous
renal replacement techniques.

- Intolerance to enteral feeding.

- Administration in the previous 72 h of bicarbonate or acetazolamide.

- Terminal disease.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Alkalosis

Obesity Hypoventilation Syndrome

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: Placebo

Drug: Acetazolamide

Primary Outcome(s)

Length of mechanical ventilation [Time Frame: From intubation date to extubation date, an expected average of 1 week]

Secondary Outcome(s)

Complications associated to the treatment [Time Frame: During the mechanical ventilation period, an expected average of 1 week]

All cause hospital mortality [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks]

Length of intensive care unit stay [Time Frame: The duration of ICU stay, an expected average less than 2 weeks]

Secondary ID(s)

TRAMA study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors