Pulmonary Disease, Chronic Obstructive Clinical Trial
— TRAMAOfficial title:
Effects of Acetazolamide on the Duration of Mechanical Ventilation in Patients With Metabolic Alkalosis. Phase III Multicenter Double-blinded Clinical Trial.
Verified date | March 2015 |
Source | Hospital Son Llatzer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 140 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Fundació Hospital Asil de Granollers | Granollers | Barcelona |
Spain | Fundación Jiménez Díaz | Madrid | Comunidad de Madrid |
Spain | Hospital Universitario Infanta Leonor | Madrid | Comunidad de Madrid |
Spain | Hospital de Manacor | Manacor | Illes Balears |
Spain | Hospital Son Espases | Palma de Mallorca | Illes Balears |
Spain | Hospital Son Llàtzer | Palma de Mallorca | Illes Balears |
Spain | Hospital de Sant Joan Despí Moisès Broggi | Sant Joan Despí | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Son Llatzer |
Spain,
Banga A, Khilnani GC. Post-hypercapnic alkalosis is associated with ventilator dependence and increased ICU stay. COPD. 2009 Dec;6(6):437-40. doi: 10.3109/15412550903341448. — View Citation
Faisy C, Mokline A, Sanchez O, Tadié JM, Fagon JY. Effectiveness of acetazolamide for reversal of metabolic alkalosis in weaning COPD patients from mechanical ventilation. Intensive Care Med. 2010 May;36(5):859-63. doi: 10.1007/s00134-010-1795-7. Epub 2010 Mar 9. — View Citation
Mazur JE, Devlin JW, Peters MJ, Jankowski MA, Iannuzzi MC, Zarowitz BJ. Single versus multiple doses of acetazolamide for metabolic alkalosis in critically ill medical patients: a randomized, double-blind trial. Crit Care Med. 1999 Jul;27(7):1257-61. — View Citation
Moviat M, Pickkers P, van der Voort PH, van der Hoeven JG. Acetazolamide-mediated decrease in strong ion difference accounts for the correction of metabolic alkalosis in critically ill patients. Crit Care. 2006 Feb;10(1):R14. — View Citation
Raurich JM, Rialp G, Ibáñez J, Llompart-Pou JA, Ayestarán I. Hypercapnic respiratory failure in obesity-hypoventilation syndrome: CO2 response and acetazolamide treatment effects. Respir Care. 2010 Nov;55(11):1442-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of mechanical ventilation | From intubation date to extubation date, an expected average of 1 week | No | |
Secondary | Length of intensive care unit stay | The duration of ICU stay, an expected average less than 2 weeks | No | |
Secondary | All cause hospital mortality | 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 | No |
Secondary | Complications associated to the treatment | 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 | Yes |
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