Trial document




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  DRKS00000704

Trial Description

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Title

Obstructive sleep apnea (OSA) postoperative risk stratification trial

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Trial Acronym

OSARST

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Nocturnal cessation of breathing associated with snoring (sleep apnea) ist one of the most frequent diseases in advanced age. Up to now it is unknown, whether sleep apnea influences recovery after surgery. Therefore the study aims to evaluate, if sleep apnea has a negative impact on recovery after cardiac surgery (Bypass surgery). Patients will be investigated in the sleep lab before surgery and potential sleep apnea can be diagnosed. After surgery recovery process will be tightly monitored.

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Brief Summary in Scientific Language

Obstructive sleep apnea (OSA), characterized by recurrent nocturnal episodes of upper airway obstruction, has a prevalence of 26 % in the middle-aged population. Retrospective studies suggest that OSA increases postoperative morbidity and mortality after surgery. Prospective studies, investigating this association, are lacking.The study aims to evaluate prospectively, if pre-existing OSA increases postoperative morbidity and mortality and enhances susceptibility for infectious complications in patients undergoing elective coronary bypass surgery. Patients will be screened for OSA before surgery and potential postoperative complications in relation to preexisiting OSA will be analyzed.

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Organizational Data

  •   DRKS00000704
  •   2011/01/27
  •   [---]*
  •   yes
  •   Approved
  •   2900-08/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G47.3 -  Sleep apnoea
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Interventions/Observational Groups

  •   Observational group 1: Patients with OSA undergoing elective coronary bypass surgery.
  •   Observational group 2: Patients without OSA undergoing elective coronary bypass surgery.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Blinded
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  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
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Primary Outcome

Composite end point of postoperative cardiac (reanimation, cardiogenic shock, myocardial ischemia, implantation of a permanent pacemaker), respiratory (acute respiratory failure, reintubation, tracheostomy, prolonged mechanical ventilation >24 hours), neurological (stroke), surgical (reoperation), renal (acute renal failure requiring dialysis), infectious (sepsis, deep wound infection, pneumonia) complications, occurring within 7 days or death within 30 days after coronary artery bypass graft surgery in relation to preexisting OSA.

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Secondary Outcome

•Hospital length of stay (days)
•Length of postoperative stay on ICU (hours)
•ICU transferral (events)
•Postoperative cardiac complications and interventions
•Postoperative respiratory complications and interventions
•Postoperative neurological complications
•Postoperative surgical complications and interventions
• Postoperative acute renal failure, requiring dialysis
• Postoperative infectious complications
•Postoperative SIRS, Sepsis and septic shock
•Length of postoperative mechanical ventilation
•Reanimation
•Mortality at discharge from hospital and within 30 days after surgery
•Predispositional factors for infectious complications in OSA such as autonomic, endothelial dysfunction, proinflammatory state and hypercoagulability

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/02/01
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Consecutive patients undergoing elective coronary artery bypass graft surgery.

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Exclusion Criteria

•Global respiratory failure
•Heart failure (NYHA III-IV)
•Acute myocardial infarction
•Immune suppression for any reason (for example AIDS,leukaemia, chemotherapy)
•Alcoholic disease
•Progressive cancer disease
•Renal failure requiring dialysis
•Pretreated OSA (CPAP-therapy)
•Hepatic failure (Child-Pugh C)

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Addresses

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    • Center for Sepsis Control and Care (CSCC), University Hospital Jena
    • Mr.  Dr. med.  Sven  Rupprecht 
    • Erlanger Allee 101
    • 07747   Jena
    • Germany
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    • Herz- und Kreislaufzentrum Rotenburg a. d. Fulda
    • Mr.  PD Dr. med.  A.  Rastan 
    • Heinz-Meise-Straße 100
    • 36199  Rotenburg a. d. Fulda
    • Germany
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    • Center for Sepsis Control and Care (CSCC), University Hospital Jena
    • Mr.  Dr. med.  Sven  Rupprecht 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Center for Sepsis Control and Care (CSCC), University Hospital Jena
    • Mr.  Dr. med.  Sven  Rupprecht 
    • Erlanger Allee 101
    • 07749   Jena
    • Germany
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Sources of Monetary or Material Support

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    • Center for Sepsis Control and Care (CSCC), University Hospital Jena
    • 07747  Jena
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.