Trial Outcomes & Findings for Extracardiac Complications After Cardiac Surgery (NCT NCT01187004)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

164 participants

Primary outcome timeframe

at seven days after intervention

Results posted on

2013-02-12

Participant Flow

We enrolled all patients undergoing a cardiac surgery intervention on cardiopulmonary by pass (CPB)

Patients were excluded for: Intensive Care Unit - Length of stay (ICU-LOS)\<24h, age \< 18 yrs old; mechanical ventilation before surgery; Acute Lung Injury (ALI) at the admission to Intensive Care Unit (ICU); heart and lung transplant

Participant milestones

Participant milestones
Measure	Acute Lung Injury (ALI) Group patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass	Control Group patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
Overall Study STARTED	20	144
Overall Study COMPLETED	20	144
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extracardiac Complications After Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Lung Injury (ALI) Group n=20 Participants patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass	Control Group n=144 Participants patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass	Total n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	57 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	87 Participants n=7 Participants	100 Participants n=5 Participants
Age Continuous	69 years STANDARD_DEVIATION 10 • n=5 Participants	65 years STANDARD_DEVIATION 14 • n=7 Participants	66 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	38 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	106 Participants n=7 Participants	117 Participants n=5 Participants
Region of Enrollment Italy	20 participants n=5 Participants	144 participants n=7 Participants	164 participants n=5 Participants

PRIMARY outcome

Timeframe: at seven days after intervention

Population: Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of 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.

Outcome measures

Outcome measures
Measure	Acute Lung Injury n=164 Participants Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation	Control Group patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
Acute Lung Injury After Cardiac Surgery	20 participants Interval 6.0 to 16.0	—

SECONDARY outcome

Timeframe: at 28 days

Population: The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value

If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.

Outcome measures

Outcome measures
Measure	Acute Lung Injury n=20 Participants Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation	Control Group n=144 Participants patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
Intensive Care Unit (ICU) Length of Stay	22 days Inter-Quartile Range 54 • Interval 4.0 to 26.0	2 days Interval 1.0 to 26.0

Adverse Events

Acute Lung Injury (ALI) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Daniela Pasero

UTurin

Phone: 00390116335511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place