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Detailed statistical analysis plan for the pulmonary protection trial.

Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbrüchel DA, Wetterslev J - Trials (2014)

Bottom Line: Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass.The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter.Secondary outcome measures are oral tracheal intubation time, days alive outside the intensive care unit, days alive outside the hospital, and 30- and 90-day mortality, and one or more of the following selected serious adverse events: pneumothorax or pleural effusion requiring drainage, major bleeding, reoperation, severe infection, cerebral event, hyperkaliemia, acute myocardial infarction, cardiac arrhythmia, renal replacement therapy, and readmission for a respiratory-related problem.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiothoracic Anaesthesiology, The Heart Centre, Rigshospitalet 4142, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. katrine.buggeskov@gmail.com.

ABSTRACT

Background: Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass. The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease. This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias, selective reporting, and data-driven results as an update to the published design and method for the trial.

Results: The pulmonary protection trial is a randomized, parallel group clinical trial that assesses the effect of pulmonary perfusion with oxygenated blood or Custodiol™ HTK (histidine-tryptophan-ketoglutarate) solution versus no pulmonary perfusion in 90 chronic obstructive pulmonary disease patients. Patients, the statistician, and the conclusion drawers are blinded to intervention allocation. The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter. Secondary outcome measures are oral tracheal intubation time, days alive outside the intensive care unit, days alive outside the hospital, and 30- and 90-day mortality, and one or more of the following selected serious adverse events: pneumothorax or pleural effusion requiring drainage, major bleeding, reoperation, severe infection, cerebral event, hyperkaliemia, acute myocardial infarction, cardiac arrhythmia, renal replacement therapy, and readmission for a respiratory-related problem.

Conclusions: The pulmonary protection trial investigates the effect of pulmonary perfusion during cardiopulmonary bypass in chronic obstructive pulmonary disease patients. A preserved oxygenation index following pulmonary perfusion may indicate an effect and inspire to a multicenter confirmatory trial to assess a more clinically relevant outcome.

Trial registration: ClinicalTrials.gov identifier: NCT01614951, registered on 6 June 2012.

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Related in: MedlinePlus

CONSORT flow diagram. ITT, intension-to-treat; OI, oxygenation index.
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Fig1: CONSORT flow diagram. ITT, intension-to-treat; OI, oxygenation index.

Mentions: The flow of trial patients will be displayed in a Consolidated Standards of Reporting Trials (CONSORT) diagram (see Figure 1) [18]. The number of screened patients who fulfilled trial inclusion criteria, and the number included in the primary and secondary analyses, as well as all reasons for exclusions in primary and secondary analyses will be reported.Figure 1


Detailed statistical analysis plan for the pulmonary protection trial.

Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbrüchel DA, Wetterslev J - Trials (2014)

CONSORT flow diagram. ITT, intension-to-treat; OI, oxygenation index.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4307213&req=5

Fig1: CONSORT flow diagram. ITT, intension-to-treat; OI, oxygenation index.
Mentions: The flow of trial patients will be displayed in a Consolidated Standards of Reporting Trials (CONSORT) diagram (see Figure 1) [18]. The number of screened patients who fulfilled trial inclusion criteria, and the number included in the primary and secondary analyses, as well as all reasons for exclusions in primary and secondary analyses will be reported.Figure 1

Bottom Line: Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass.The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter.Secondary outcome measures are oral tracheal intubation time, days alive outside the intensive care unit, days alive outside the hospital, and 30- and 90-day mortality, and one or more of the following selected serious adverse events: pneumothorax or pleural effusion requiring drainage, major bleeding, reoperation, severe infection, cerebral event, hyperkaliemia, acute myocardial infarction, cardiac arrhythmia, renal replacement therapy, and readmission for a respiratory-related problem.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiothoracic Anaesthesiology, The Heart Centre, Rigshospitalet 4142, Blegdamsvej 9, DK-2100 Copenhagen, Denmark. katrine.buggeskov@gmail.com.

ABSTRACT

Background: Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass. The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease. This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias, selective reporting, and data-driven results as an update to the published design and method for the trial.

Results: The pulmonary protection trial is a randomized, parallel group clinical trial that assesses the effect of pulmonary perfusion with oxygenated blood or Custodiol™ HTK (histidine-tryptophan-ketoglutarate) solution versus no pulmonary perfusion in 90 chronic obstructive pulmonary disease patients. Patients, the statistician, and the conclusion drawers are blinded to intervention allocation. The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter. Secondary outcome measures are oral tracheal intubation time, days alive outside the intensive care unit, days alive outside the hospital, and 30- and 90-day mortality, and one or more of the following selected serious adverse events: pneumothorax or pleural effusion requiring drainage, major bleeding, reoperation, severe infection, cerebral event, hyperkaliemia, acute myocardial infarction, cardiac arrhythmia, renal replacement therapy, and readmission for a respiratory-related problem.

Conclusions: The pulmonary protection trial investigates the effect of pulmonary perfusion during cardiopulmonary bypass in chronic obstructive pulmonary disease patients. A preserved oxygenation index following pulmonary perfusion may indicate an effect and inspire to a multicenter confirmatory trial to assess a more clinically relevant outcome.

Trial registration: ClinicalTrials.gov identifier: NCT01614951, registered on 6 June 2012.

Show MeSH
Related in: MedlinePlus