Trial document





This trial has been registered retrospectively.
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  DRKS00005478

Trial Description

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Title

A Systematic Diagnostic And Therapeutic Approach For The Treatment Of Patients After Cardio-pulmonary Resuscitation:
A Prospective Evaluation Of 212 Patients Over 5 Years

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In this study a systematic diagnostic and therapeutic treatment strategy in patients after cardio-pulmonary resuscitation was evaluated. This included a fast ECG- and echocardiographic analysis and a rapid cardiac catheterization.

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Brief Summary in Scientific Language

Background
A systematic treatment protocol for patients after resuscitation is missing.
Methods
We evaluated a systematic protocol including ECG, echocardiogram, urgent cardiac catheterisation (“STEMI-like” workflow), CT scans, laboratory findings, IABP, hypothermia and cMRI prospectively over 5 years. The primary endpoint was the Cerebral Perfomance Category Scale (CPCS).
Results
During the period from January 2008 to December 2012 212 patients were included. Mean age was 66.7 years, n= 151 (71.2 %) were male, mean time from first medical contact to start of catheterisation was 76.6 minutes, ventricular fibrillation (VF) n= 99 (46.7 %).
A significant coronary artery stenosis was seen in n= 130 (61.3 %), PCI was performed in n= 101 (47.6 %), an ACS was found in n= 100 (47.2 %), n= 91 patients (42.9 %) had another cardiac cause, an extracardiac cause was found in n= 12 (5.7 %, mostly a cerebral process), in 9 patients (4.3 %) no cause was identifiable.
A significant difference in mortality was found for patients with TIMI flow 2/3 vs 0/1 (65.4 % vs. 95.7, p< 0.01). The difference of intra-aortic balloon pumping vs. no pumping was not significant, hypothermia reduced mortality significantly (52.7 % vs 68.2 %, p=0.04).
The survival rate was n=76 (35.9 %), a CPCS of 1/2 was reached in n= 67 pts (31.8 %), patients with ongoing resuscitation had a 100 % mortality (n= 41), VF had a lower mortality (54.6 % vs. 72.6 %, p< 0.01).
Conclusion
A systematic algorithm can improve the outcome of patients after reanimation.

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Organizational Data

  •   DRKS00005478
  •   2013/12/13
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   [---]*, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   Resuscitation
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Interventions/Observational Groups

  •   Observational study: a specific diagnostic and therapeutic treatment algorithm (including ECG, echocardiography, rapid cardiac catheterization, cMRT, myocardial biopsy, CT scan) is proofed for the care of patients after resuscitation. There is no other treatment group.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Cerebral Perfomance Category Scale (CPCS) at the end of the hospital stay of the patient (neurological examination)

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Secondary Outcome

mortality during the hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2008/01/02
  •   212
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   95   Years
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Additional Inclusion Criteria

resuscitation

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Exclusion Criteria

trauma, accident, gastrointestinal bleeding

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Addresses

  • start of 1:1-Block address primary-sponsor
    • HetzelstiftDepartment of Cardiology
    • Mr.  Dr  Hubertus  von Korn 
    • Stiftstr. 10
    • 67434  Neustadt
    • Germany
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    • Hetzelstift
    • Mr.  Dr  Hubertus  von Korn 
    • Stiftstrasse 10
    • 67435  Neustadt
    • Germany
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  • start of 1:1-Block address public-contact
    • Hetzelstift
    • Mr.  Dr  Hubertus  von Korn 
    • Stiftstrasse 10
    • 67435  Neustadt
    • Germany
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Sources of Monetary or Material Support

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    • Hetzelstift
    • Mr.  Dr  Hubertus  von Korn 
    • Stiftstrasse 10
    • 67435  Neustadt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/31
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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.