Metabolic Alkalosis, Obesity Hypoventilation Syndrome, Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome, Alkalosis, Respiration, Artificial, Acetazolamide, Intensive care, Adult
Brief summary
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).
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.
Interventions
DRUGAcetazolamide
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.
DRUGPlacebo
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.
Sponsors
Hospital Son Llatzer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of mechanical ventilation | From intubation date to extubation date, an expected average of 1 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of intensive care unit stay | The duration of ICU stay, an expected average less than 2 weeks | — |
| All cause hospital mortality | 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 |
| Complications associated to the treatment | 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. |
Countries
Spain
Outcome results
None listed