NCT01627639

Brief Summary

The purpose of this study is to determine whether acetazolamide are effective to reduce the length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease (COPD) patients developing pure or mixed metabolic alkalosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

2.8 years

First QC Date

April 2, 2012

Last Update Submit

October 5, 2015

Conditions

Decompensated Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • length of invasive mechanical ventilation

    within the first 28 days after intubation

Secondary Outcomes (5)

  • Length of weaning from mechanical ventilation

    once at the extubation or at day 28

  • weaning success

    once at the end of ICU stay or at Day 28

  • numbers of nosocomial infections

    every day during 28 days

  • length of ICU stay

    once at the end of ICU stay or at Day 28

  • ICU mortality

    once at the end of ICU stay or at Day 28

Study Arms (2)

Acetazolamide

ACTIVE COMPARATOR

Acetazolamide (1 g IV per day or 2 g IV per day if coprescription of loop diuretics) or Placebo (saline serum) when pure or mixed metabolic alkalosis being present until planned extubation

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AcetazolamideDRUG

Acetazolamide (1 g IV per day or 2 g IV per day if coprescription of loop diuretics) or Placebo (saline serum) when pure or mixed metabolic alkalosis being present until planned extubation

Acetazolamide
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75015, France

Location

Related Publications (3)

  • Heming N, Faisy C, Urien S. Population pharmacodynamic model of bicarbonate response to acetazolamide in mechanically ventilated chronic obstructive pulmonary disease patients. Crit Care. 2011;15(5):R213. doi: 10.1186/cc10448. Epub 2011 Sep 14.

    PMID: 21917139BACKGROUND

  • Chang WT, Thayer DW. The cellulase system of a Cytophaga species. Can J Microbiol. 1977 Sep;23(9):1285-92. doi: 10.1139/m77-192.

    PMID: 20217BACKGROUND

  • Faisy C, Meziani F, Planquette B, Clavel M, Gacouin A, Bornstain C, Schneider F, Duguet A, Gibot S, Lerolle N, Ricard JD, Sanchez O, Djibre M, Ricome JL, Rabbat A, Heming N, Urien S, Esvan M, Katsahian S; DIABOLO Investigators. Effect of Acetazolamide vs Placebo on Duration of Invasive Mechanical Ventilation Among Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):480-8. doi: 10.1001/jama.2016.0019.

    PMID: 26836730DERIVED

MeSH Terms

Interventions

Acetazolamide

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Christophe Faisy, MD, PhD

    Medical Intensive Care Unit, European Georges Pompidou Hospital, Asssistance Publique - Hôpitaux de Paris, Paris Descartes University, Paris, FRance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2012

First Posted

June 26, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations

FR(1)