Extracardiac Complications After Cardiac Surgery

NCT ID: NCT01187004

Last Updated: 2013-02-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Lung Injury Sepsis Infections Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Lung Injury (ALI)

patients who might develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Daniela Pasero

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mauro Rinaldi, MD

Role: STUDY_CHAIR

San Giovanni Battista Hospital, University of Turin

Locations

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Cardiac Intensive Care Unit, San Giovanni Battista Hospital

Turin, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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82755

Identifier Type: -

Identifier Source: org_study_id

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