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

This study is currently recruiting participants.
Verified December 2011 by Hospital Son Llatzer
Sponsor:
Information provided by (Responsible Party):
Gemma Rialp, Hospital Son Llatzer
ClinicalTrials.gov Identifier:
NCT01499485
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Obesity Hypoventilation Syndrome
Metabolic Alkalosis
 Drug: Acetazolamide
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Son Llatzer:

Primary Outcome Measures:
  • Length of mechanical ventilation [ Time Frame: From intubation date to extubation date, an expected average of 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of intensive care unit stay [ Time Frame: The duration of ICU stay, an expected average less than 2 weeks ] [ Designated as safety issue: No ]
  • All cause hospital mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Plasma and urine analysis will be performed to detect alteration in electrolites or renal function.


Estimated Enrollment: 140
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Edemox
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499485

Contacts
Contact: Gemma Rialp, MD; PhD 0034871202133 grialp@gmail.es

Locations
Spain
Fundació Hospital Asil de Granollers Recruiting
Granollers, Barcelona, Spain, 08402
Contact: Pau Garro, MD            
Sub-Investigator: Pau Garro, MD            
Hospital de Sant Joan Despí Moisès Broggi Recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Contact: Arantxa Mas, MD            
Sub-Investigator: Arantxa Mas, MD            
Fundación Jiménez Díaz Recruiting
Madrid, Comunidad de Madrid, Spain, 28040
Contact: Manuel Pérez-Márquez, PhD;MD            
Sub-Investigator: Manuel Pérez-Márquez, MD;PhD            
Hospital Universitario Infanta Leonor Recruiting
Madrid, Comunidad de Madrid, Spain, 28031
Contact: Gabriel Heras, MD            
Sub-Investigator: Gabriel Heras, MD            
Hospital de Manacor Recruiting
Manacor, Illes Balears, Spain, 07500
Contact: Margalida Vilar, MD            
Sub-Investigator: Margalida Vilar, MD            
Hospital Son Espases Recruiting
Palma de Mallorca, Illes Balears, Spain, 07010
Contact: Joan M Raurich, MD;PhD            
Sub-Investigator: Joan M Raurich, MD;PhD            
Hospital Son Llàtzer Recruiting
Palma de Mallorca, Illes Balears, Spain, 07198
Contact: Gemma Rialp, MD;PhD     0034 871202133     grialp@gmail.com    
Principal Investigator: Gemma Rialp, MD;PhD            
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Indalecio Morán, MD            
Sub-Investigator: Indalecio Morán, MD            
Sponsors and Collaborators
Hospital Son Llatzer
  More Information

Publications:

Responsible Party: Gemma Rialp, MD; PhD, Hospital Son Llatzer
ClinicalTrials.gov Identifier: NCT01499485     History of Changes
Other Study ID Numbers: TRAMA study
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Son Llatzer:
Pulmonary Disease, Chronic Obstructive
Obesity Hypoventilation Syndrome
Alkalosis
Respiration, Artificial
 Acetazolamide
Intensive care
Adult

Additional relevant MeSH terms:
Alkalosis
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Obesity
Obesity Hypoventilation Syndrome
Hypoventilation
Respiratory Insufficiency
Acid-Base Imbalance
Metabolic Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Acetazolamide
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013