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

March 16, 2015 updated by: Gemma Rialp, Hospital Son Llatzer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
    • Barcelona
      • Granollers, Barcelona, Spain, 08402
        • Fundació Hospital Asil de Granollers
      • Sant Joan Despí, Barcelona, Spain, 08970
        • Hospital de Sant Joan Despí Moisès Broggi
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Madrid, Comunidad de Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
    • Illes Balears
      • Manacor, Illes Balears, Spain, 07500
        • Hospital de Manacor
      • Palma de Mallorca, Illes Balears, Spain, 07198
        • Hospital Son Llatzer
      • Palma de Mallorca, Illes Balears, Spain, 07010
        • Hospital Son Espases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo

Daily morning ABGA:

  • If actual bicarbonate > 26 mmol/L and pH > 7.35: administration of enteral capsule of placebo.
  • If actual bicarbonate > 26 mmol/L and pH <= 7.35, increase minute ventilation to reach pH > 7.35 and then administer enteral capsule of placebo.
  • If actual bicarbonate <= 26 mmol/L: omit treatment that day.
Experimental: Acetazolamide
Drug: Acetazolamide

Daily morning ABGA:

  • If actual bicarbonate > 26 mmol/L and pH > 7.35: administration of enteral capsule of acetazolamide 500 mg .
  • If actual bicarbonate > 26 mmol/L and pH <= 7.35, increase minute ventilation to reach pH > 7.35 and then administer enteral capsule of acetazolamide 500 mg.
  • If actual bicarbonate <= 26 mmol/L: omit treatment that day.
Other Names:
  • Edemox

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of intensive care unit stay
Time Frame: The duration of ICU stay, an expected average less than 2 weeks
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
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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.
During the mechanical ventilation period, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Llatzer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAMA study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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