Extracardiac Complications After Cardiac Surgery

Completed

• Conditions: Acute Lung Injury; Sepsis; Infections; Acute Kidney Injury

• Registration Number: NCT01187004
• Lead Sponsor: University of Turin, Italy

Brief Summary

Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.

Detailed Description

To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Results First Submitted: 2011-08-08
• Results First Submitted QC: 2011-11-30
• Results First Posted: 2012-01-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• cardiac intervention with cardiopulmonary by pass, age > 18 years old

Exclusion Criteria

• off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Lung Injury After Cardiac Surgery	at seven days after intervention	to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 \<300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.

Secondary Outcome Measures

Name	Time	Method
Intensive Care Unit (ICU) Length of Stay	at 28 days	If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.

Trial Locations

Locations (1)

Cardiac Intensive Care Unit, San Giovanni Battista Hospital; 🇮🇹 Turin, Italy