Extracardiac Complications After Cardiac Surgery

Sepsis Clinical Trial

Official title:

Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187004
• Other study ID #: 82755
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: February 5, 2013
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: February 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• Infections
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Sepsis

Locations

Country	Name	City	State
Italy	Cardiac Intensive Care Unit, San Giovanni Battista Hospital	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Lung Injury After Cardiac Surgery	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.	at seven days after intervention	No
Secondary	Intensive Care Unit (ICU) Length of Stay	If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.	at 28 days	No