Trial document




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  DRKS00004886

Trial Description

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Title

A randomized controlled comparison of total intravenous anaesthesia and balanced anaesthesia for interventional repair of mitral regurgitation: myocardial ischemia and haemodynamics.

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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 this trial is to compare two different kinds of general anaesthesia, total intravenous anaesthesia and balanced anaesthesia, for the implantation of the MitraClip®-System. The main focus will be, whether the choice of anaesthesia influences the damage the heart might sustain during the procedure and whether the choice of anaesthesia influences blood pressure an cardiac function differently.
To asses damage to the heart, Troponin I, a marker of myocardial cell death, will be measured 24 hours after induction of anaesthesia. Also, an electrocardiogram (ECG) will be taken at this time.
During general anaesthesia advanced haemodynamic monitoring will be implemented to asses cardiac function continuously. Therefore critical loss of cardiac function will be detected earlier and treated more easily.

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Brief Summary in Scientific Language

New catheter-based corrections of cardiac valve dysfunctions, like TAVI or MitraClip® are generally implanted with the patient in general anaesthesia.
So far nothing is known whether the choice of anaesthetics influences patients outcome after mitral clipping. However balanced anaesthesia compared to total intravenous anaesthesia for coronary artery bypass surgery is associated with less myocardial damage as measured with troponin I release while preconditioning with sevoflorane does not influence troponin I release during percutaneous coronary intervention. For surgical mitral valve repair only the subgroup of the patients with coronary artery disease had less troponin I release when treated with inhalational anaesthetics.
In non-cardiac surgery the choice of anaesthetic does not influence the incidence of cardiac ischaemia.
The aim of this study is to compare total intravenous anaesthesia and balanced anaesthesia for implantation of the MitraClip®-System. To asses myocardial damage troponin I release will be measured 24 hours after induction of general anaesthesia.

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Organizational Data

  •   DRKS00004886
  •   2013/04/17
  •   [---]*
  •   yes
  •   Approved
  •   EA4/019/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I34.0 -  Mitral (valve) insufficiency
  •   R11 -  Nausea and vomiting
  •   F05.8 -  Other delirium
  •   I24 -  Other acute ischaemic heart diseases
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Interventions/Observational Groups

  •   Total intravenous anaesthesia (TIVA: Propofol + Remifentanil) for percutanuous correction of severe mitral regurgitation with the MitraClip-System.
  •   Balanced anaesthesia (Desflurane + Remifentanil) for percutanuous correction of severe mitral regurgitation with the MitraClip-System.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

troponin I release 24 hours after induction of general anaesthesia

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Secondary Outcome

- myocardial infarction, defined as new Q-wave >= 40 ms in at least two corresponding leads or loss of R-wave in V1 to V6 or TnI >11,6 µg/l 24h post induction of general anaesthesia

- changes in ST-segment during or after intervention

- maximum decrease of cardiac output during intervention as measured with thermodilution method (PiCCO®) and with transesophageal echocardiography (TEE) immediately before and after induction of general anaesthesia, after 30 min, after mitral clipping and at the end of the procedure

- maximum decrease in mid arterial pressure during intervention

- accumulated time of hypotension defined as systolischer arterial pressure > -20% (compared to systolic blood pressure at time of assesment for anaesthesia) or mid arterial pressure (MAD) < 60 mmHg

- accumulated dosage of vasopressors and/or ionotropes (noradrenalin, adrenalin, dobutamin) during intervention

- conditions for intervention

- duration of intervention

- intensive care and hosptal length of stay (days)

- incidence of post-interventional delirium

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/04/19
  •   84
  •   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

• age>18 years
• informed consent for MitraClip®
• informed consent for general anaesthesia
• informed consent of anaesthesiologist

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Exclusion Criteria

• age <18 years
• missing informes consent
• myocardial infarction during last 6 weeks before intervention
• contraindications against Propofole, inhalative anaesthetics, Remifentanil, CisAtracurium
• use of sulfonylurea, theophylline or allopurinol
• history of inguinal vascular surgery

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Addresses

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    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Charité - Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Charité - Campus Benjamin Franklin
    • Mr.  Dr. med.  Jan   Kügler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Charité - Campus Benjamin Franklin
    • Mr.  Dr. med.  Jan  Kügler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Status

  •   Recruiting suspended on temporary hold
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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.