NCT00498251

Brief Summary

Background : Acute lung injury (ALI) occasionally occurs after pulmonary resection and carries a bad prognosis with a high mortality rate ranging from 20 to 100%. Objectives :

  • Prospective controlled trial including surgical patients with high risk factors for ALI (n=60) allocated to receive inhaled drugs (randomised, double-blind, cross-over mode).
  • Main measurements: Intra-thoracic blood volume, intra- and extra-vascular lung water, hemodynamic parameters (CO, systolic arterial pressure/flow variations, dPmax, MAP, CVP), oxygenation indices (PaO2/FIO2), ventilatory parameters, clinical outcome data, histochemical and pathological data. Glossary CO = cardiac output; dPmax = maximal arterial pressure slope; SAP-V = systolic arterial pressure variations; Flow-V = Flow variations; MAP = mean arterial pressure; CVP = central venous pressure; PaO2=arterial oxygen pressure; FIO2= oxygen inspiratory fraction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable

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

September 1, 2004

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
Last Updated

July 10, 2007

Status Verified

June 1, 2007

First QC Date

July 6, 2007

Last Update Submit

July 9, 2007

Conditions

Lung Injury, AcuteThoracotomyAnesthesiaIntensive Care, SurgicalExtravascular Lung Water

Keywords

lung injury, acutethoracic surgical procedureslung cancersalbutamol

Outcome Measures

Primary Outcomes (1)

  • reduction in extravascular lung water

    within the first 24 hours after lung surgery

Secondary Outcomes (1)

  • changes in oxygenation indices, hemodynamics and radiological lung injury score

    within the first 48 hours

Interventions

inhalation of salbutamol (5 mg)DRUG
ipratropiumDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with at least 3 risk factors for postoperative lung edema
  • age \> 60 yrs
  • history of chronic alcohol consumption (\>60g/day)
  • prior radiation or chemotherapy
  • cardiac insufficiency (left ventricular ejection fraction \< 40%, or a history of past acute heart failure)
  • coronary artery disease (history of myocardial infarct, Q wave on the ECG, positive stress test or coronary angiogram)
  • recent pneumonia (within 6 weeks of hospital admission)
  • reduced diffusion capacity for carbon monoxide (DLCO \< 60% of predicted values)
  • predicted postoperative lung perfusion of \< 55% of total lung perfusion

You may not qualify if:

  • pneumonectomy
  • intracardiac shunts
  • valvular diseases
  • aortic abdominal aneurysm
  • chronic treatment with inhaled bronchodilators
  • a history of any adverse reaction to bronchodilators
  • liver or kidney insufficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Geneva

Geneva, CH-1211, Switzerland

Location

Related Publications (1)

  • Licker M, Tschopp JM, Robert J, Frey JG, Diaper J, Ellenberger C. Aerosolized salbutamol accelerates the resolution of pulmonary edema after lung resection. Chest. 2008 Apr;133(4):845-52. doi: 10.1378/chest.07-1710. Epub 2007 Nov 7.

    PMID: 17989152DERIVED

MeSH Terms

Conditions

Acute Lung InjuryLung Neoplasms

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Christoph Ellenberger, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 10, 2007

Study Start

September 1, 2004

Study Completion

June 1, 2007

Last Updated

July 10, 2007

Record last verified: 2007-06

Locations

CH(1)