NCT01499485

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2011

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

December 20, 2011

Last Update Submit

March 16, 2015

Conditions

Pulmonary Disease, Chronic ObstructiveObesity Hypoventilation SyndromeMetabolic Alkalosis

Keywords

Pulmonary Disease, Chronic ObstructiveObesity Hypoventilation SyndromeAlkalosisRespiration, ArtificialAcetazolamideIntensive careAdult

Outcome Measures

Primary Outcomes (1)

  • Length of mechanical ventilation

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

Secondary Outcomes (3)

  • 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

  • Complications associated to the treatment

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

Study Arms (2)

Acetazolamide

EXPERIMENTAL
Drug: Acetazolamide

placebo

PLACEBO COMPARATOR
Drug: Placebo

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.

Also known as: Edemox
Acetazolamide
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.

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital de Manacor

Manacor, Balearic Islands, 07500, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Fundació Hospital Asil de Granollers

Granollers, Barcelona, 08402, Spain

Location

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28031, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Related Publications (6)

  • Faisy C, Mokline A, Sanchez O, Tadie 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.

    PMID: 20217045BACKGROUND

  • Raurich JM, Rialp G, Ibanez J, Llompart-Pou JA, Ayestaran I. Hypercapnic respiratory failure in obesity-hypoventilation syndrome: CO(2) response and acetazolamide treatment effects. Respir Care. 2010 Nov;55(11):1442-8.

    PMID: 20979670BACKGROUND

  • 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. doi: 10.1097/00003246-199907000-00004.

    PMID: 10446816BACKGROUND

  • 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.

    PMID: 19938966BACKGROUND

  • 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. doi: 10.1186/cc3970.

    PMID: 16420662BACKGROUND

  • Rialp Cervera G, Raurich Puigdevall JM, Moran Chorro I, Martin Delgado MC, Heras la Calle G, Mas Serra A, Vallverdu Perapoch I. Effects of early administration of acetazolamide on the duration of mechanical ventilation in patients with chronic obstructive pulmonary disease or obesity-hypoventilation syndrome with metabolic alkalosis. A randomized trial. Pulm Pharmacol Ther. 2017 Jun;44:30-37. doi: 10.1016/j.pupt.2017.03.002. Epub 2017 Mar 7.

    PMID: 28286047DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveObesity Hypoventilation SyndromeAlkalosisRespiratory Aspiration

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesAcid-Base ImbalanceMetabolic Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 26, 2011

Study Start

November 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

ES(8)