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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Acetazolamide on the Duration of Mechanical Ventilation in Patients With Metabolic Alkalosis. Phase III Multicenter Double-blinded Clinical Trial.

Brief Summary: 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).

Detailed Summary:

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.


Sponsor: Hospital Son Llatzer

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of intensive care unit stay [ Time Frame: The duration of ICU stay, an expected average less than 2 weeks ]
  • All cause hospital mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    Alive or dead status will be recorded at the end of hospital stay
  • Complications associated to the treatment [ Time Frame: During the mechanical ventilation period, an expected average of 1 week ]
    Plasma and urine analysis will be performed to detect alteration in electrolites or renal function.


Original Secondary Outcome: Same as current

Information By: Hospital Son Llatzer

Dates:
Date Received: December 20, 2011
Date Started: November 2011
Date Completion:
Last Updated: March 16, 2015
Last Verified: March 2015