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Completed

NCT Number: NCT01499485

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

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).

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Acid-Base Imbalance Alkalosis Apnea Chronic Disease Disease Attributes Dyssomnias Hypoventilation Lung Diseases Lung Diseases, Obstructive Metabolic Alkalosis Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity Hypoventilation Syndrome Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Manacor, Manacor, Balearic Islands, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetazolamide

Drug

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

Placebo

Drug

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.

Primary outcomes

  1. Length of mechanical ventilation

    Time frame: From intubation date to extubation date, an expected average of 1 week

Secondary outcomes

  1. Length of intensive care unit stay

    Time frame: The duration of ICU stay, an expected average less than 2 weeks

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Registry information

Official study title

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

Acronym: TRAMA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 26, 2011
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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