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

Hospital Son Llatzer

Status and phase

Completed

Phase 3

Conditions

Metabolic Alkalosis

Pulmonary Disease, Chronic Obstructive

Obesity Hypoventilation Syndrome

Treatments

Drug: Placebo

Drug: Acetazolamide

Study type

Interventional

Funder types

Other

Identifiers

NCT01499485

TRAMA study

Details and patient eligibility

About

The purpose of this study is to analyze whether the treatment of metabolic alkalosis with acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or with obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation (MV).

Full description

Metabolic alkalosis (MA) may reduce central respiratory drive, cardiac output and worsen oxygenation, leading to a delay in weaning from MV. Acetazolamide is a carbonic anhydrase inhibitor that is able to correct MA and to stimulate respiratory drive. There is a paucity of studies on the outcome of patients with MA under MV treated with acetazolamide.

The primary objective of our study is to analyze whether the treatment of MA with acetazolamide in intubated patients with COPD or with OHS reduces the length of MV, reduces the length of ICU stay or ICU mortality. Complications associated with acetazolamide treatment will be also analyzed.

Phase III double-blinded trial, with COPD or OHS patients under MV who have pH > 7,35 and bicarbonate > 28 mEq/L. Patients will be randomized to receive 500 mg of acetazolamide or placebo. According to arterial blood gas analysis (ABGA) values treatment administration will be evaluated daily until extubation.

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.