Prevention of Lung Edema After Thoracic Surgery - Full Text View

Sponsor:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00498251

Purpose

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 :

to evaluate pre-, intra- and postoperative changes in hemodynamics, oxygenation indices as well as intra- and extravascular lung water using simple thermodilution technique and continuous arterial pressure analysis
to test the efficacy of inhaled beta2 -adrenergic agonist versus anticholinergic agents to reduce lung edema in patients undergoing thoracic surgery and in pigs subjected to lipolysacharide-induced ALI.

Design of the research protocol:

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

Condition	Intervention
Lung Injury, Acute Thoracotomy Anesthesia Intensive Care, Surgical Extravascular Lung Water	Drug: inhalation of salbutamol (5 mg) Drug: ipratropium

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Does Inhaled Salbutamol Prevent Lung Edema After Thoracic Surgery? A Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Albuterol Ipratropium bromide Levalbuterol hydrochloride Albuterol sulfate Ipratropium Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

reduction in extravascular lung water [ Time Frame: within the first 24 hours after lung surgery ]

Secondary Outcome Measures:

changes in oxygenation indices, hemodynamics and radiological lung injury score [ Time Frame: within the first 48 hours ]

Enrollment:	30
Study Start Date:	September 2004
Study Completion Date:	June 2007

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498251

Locations

Switzerland
University Hospital of Geneva
Geneva, Switzerland, CH-1211

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:

Christoph Ellenberger, MD

University Hospital, Geneva

More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Nov 7.

ClinicalTrials.gov Identifier:	NCT00498251 History of Changes
Other Study ID Numbers:	CER03-160
Study First Received:	July 6, 2007
Last Updated:	July 9, 2007
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:

lung injury, acute
thoracic surgical procedures
lung cancer
salbutamol

Additional relevant MeSH terms:

Pulmonary Edema
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Albuterol
Ipratropium
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012