Prevention of Lung Edema After Thoracic Surgery
This study has been completed.
Sponsor:
University Hospital, Geneva
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00498251
First received: July 6, 2007
Last updated: July 9, 2007
Last verified: June 2007
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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:
Drug Information available for:
Albuterol
Ipratropium bromide
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
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):
| 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 May 19, 2013