Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00003327

Trial Description

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Title

Cerebral near infrared spectroscopy for prediction of central desaturation in sepsis

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Trial Acronym

NIRSep

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study examines the possibility of monitoring centralvenous saturation of patients with sepsis by using an optical method to estimate the near-infrared spectroscopy. This value is used to monitor the circulatory function of critically ill patients.

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Brief Summary in Scientific Language

Hemodynamic optimization is an important component in early and targeted sepsis therapy. Central venous saturation is one of the defined target values ​​in this context, the. The aim of this study is to investigate the relationship between ScvO2 and frontalzerebralen local Near-infrared spectoscopie in surgical patients in intensive care with septic disease.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003327
  •   2013/03/12
  •   [---]*
  •   yes
  •   Approved
  •   57/12, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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

  •   A41.9 -  Sepsis, unspecified
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Interventions/Observational Groups

  •   Sepsis. Patients with a septic syndrome. Relationship between central venous saturation and local cerebral near-infrared spectoscopie.
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Characteristics

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

Fontal near-infrared spectroscopy measured on the forehead and on the base of the left thumb at Admission/24h later / 48h later for the predication of central venous saturation measured in the BGA derived from central venous blood of ICU patients with septic syndromes

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Secondary Outcome

Arterial and venous lactate concentration measured , SaO2 in BGA, Blood pressure (measured invasively), catecholamines, PaO2 (in BGA), ventilation mode, ventilation parameters, FiO2, CVP, cardiac output, cardiac index, Peripheral Resistance (measured by pulse contour analysis)
Fontal near-infrared spectroscopy measured on the forehead and at the base of the left thumb at admission/24h later / 48h later for the predication of central venous saturation measured in the BGA derived from central venous blood of ICU patients with septic syndromes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/06/27
  •   50
  •   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

Sepsis diagnosed for less than 4 hours,
Age> 18 years, intensive care treatment

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Exclusion Criteria

apoplexy,
Intracerebral hemorrhage,
Patients aged <18 years,
Participation in another interventional study

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Addresses

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    • Universitätsklinikum Gießen Klinik für Anästhesieologie und Operative Intensivmedizin
    • Mr.  Prof. Dr. med.  Markus A.  Weigand 
    • Rudolph-Buchheim-Str. 7
    • 35394  Gießen
    • Germany
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    •   064198544401
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Gießen Klinik für Anästhesieologie und Operative Intensivmedizin
    • Mr.  Christian  Koch 
    • Rudolph-Buchheim-Str.7
    • 35394  Gießen
    • Germany
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    • UKGM Standort Gießen Abteilung für Anaesthesiologie, Operative Intensivmedizin und Schmerztherapie
    • Mr.  Christian  Koch 
    • Rudolf-Buchheim-Str. 7
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Anaesthesiologie, Operative Intensivmedizin und Schmerztherapie
    • Mr.  Prof. Dr.  Markus  Weigand 
    • Rudolf-Buchheim-Str. 7
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.