drugset / Trial / NCT00498251

Prevention of Lung Edema After Thoracic Surgery

NCT00498251

Completed 30 enrolled University Hospital, Geneva
RandomizedCrossoverDouble-blindTreatment

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 : 1. 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 2. 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

Timeline

Start
2004-09
Primary completion
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipratropium Small molecule 0.5 mg Inhaled
Subject Salbutamol Unknown 5 mg Inhaled

Indications