Trial document





This trial has been registered retrospectively.
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  DRKS00016631

Trial Description

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Title

EFFECTS OF POSTOPERATIVE DILTIAZEM PROPHYLAXIS FOR THE PREVENTION OF ATRIAL FIBRILLATION IN PATIENTS UNDERGOING THORACOABDOMINAL ESOPHAGECTOMY:
A RETROSPECTIVE COHORT STUDY

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of the Study is to evaluate the effect of a postoperative Prophylaxes with Dilzem for 14 days compared to standard care in Patients after oesophagusresection.

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Brief Summary in Scientific Language

The aim of the Study is to evaluate the effect of a postoperative Prophylaxes with Dilzem for 14 days compared to standard care in Patienten after oesophagusresection.

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Organizational Data

  •   DRKS00016631
  •   2019/01/31
  •   [---]*
  •   yes
  •   Approved
  •   S-493/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   I48.9 -  Atrial fibrillation and atrial flutter, unspecified
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Interventions/Observational Groups

  •   postoperative Standard care plus Dilzem prophylaxis for 14 days
  •   postoperative standard care alone
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Other
  •   N/A
  •   No
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Primary Outcome

Atrial Fibrillation within the first 90 days after surgery

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Secondary Outcome

Bradykardia, Hypotension; 30 day mortality,

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/10/24
  •   167
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

thoracoabdominal Esophagusresection

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Exclusion Criteria

incomplete data sets

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Addresses

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    • Universitätsklinik HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med  Marcel  Hochreiter 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinik HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Marcel  Hochreiter 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinik HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med  Marcel  Hochreiter 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Marcel  Hochreiter 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/01/24
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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.