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

Hospital Son Llatzer140 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Pulmonary Disease, Chronic Obstructive Obesity Hypoventilation Syndrome Metabolic Alkalosis

Interventions

AcetazolamideDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Hospital de Manacor

Manacor, Balearic Islands, Spain

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Length of mechanical ventilation

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

Secondary Outcomes

Length of intensive care unit stay

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

All cause hospital mortality

Alive or dead status will be recorded at the end of hospital stay

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Complications associated to the treatment

Plasma and urine analysis will be performed to detect alteration in electrolites or renal function.

Time frame: During the mechanical ventilation period, an expected average of 1 week

Data from ClinicalTrials.gov

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