Trial document




drksid header

  DRKS00000619

Trial Description

start of 1:1-Block title

Title

End-of-life Decision-making in Patients With Sepsis-related Organ Failure

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

EIDECS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.eidecs.uniklinikum-jena.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Decisions to limit intensive care treatment in patients who suffer from severe organ dysfunction after sepsis places a psychological burden for caregivers and relatives.

We intend to assess this burden and develop improved structures of communication which may reduce the psychological burden for staff and relatives.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The care of patients with sepsis-related organ failure on the intensive care unit (ICU) often includes end-of-life decisions (EOL-D) and communication of such decisions to relatives. This increases the psychological burden for caregivers and relatives.

The investigators intend to assess the prevalence and impact of EOL-D on ICU care-givers and relatives ("before") and to use this data to develop and implement standard operating procedures for improved decision-making and communication of these decisions ("after").

The hypothesis is that an improved communication strategy will reduce symptoms of burnout in caregivers and symptoms of anxiety and depression in relatives.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000619
  •   2010/11/29
  •   2010/11/18
  •   yes
  •   Approved
  •   2964_11/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01247792  (clinical trials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   severe sepsis
  •   A41.9 -  Septicaemia, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Behavioral: standard operating procedures for decision-making and communication regarding end-of-life decisions
  •   standard care
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Health care system
  •   Other
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1 Symptoms of burnout by MBI score in ICU caregivers (planned enrolment: n=180 in each period)
2 Symptoms of post-traumatic stress disorder by IES and HADS scores in relatives after approximately 60 - 90 days (planned enrolment n=90 in each period)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Psychological symptoms by IES, HADS or MBI subcales in caregivers or relatives, respectively;

Characteristics of patients with and without end-of-life decisions (EOL-D) including time periods (time until EOL-D, time between EOL-D until death or discharge) and 28-day and 90-day mortality rates;

Prevalence and characteristics of EOL-D;

Prevalence and characteristics of patients' advance directives;

Characteristics of EOL-D communication with relatives;

Prevalence of request for "Ethik Konsil" (counseling by an external ethical review board);

Direct costs of treatment of survivors and non-survivors;

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/12/01
  •   540
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

patients with severe sepsis

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

brain dead patients receiving therapy for organ donation

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen Center for Sepsis Control and Care (CSCC)
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Department of Anesthesiology and Intensive Care Medicine Jena University Hospital
    • Ms.  Dr. med.  Christiane  Hartog 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen Center for Sepsis Control and Care (CSCC) Universitätsklinikum Jena
    • Ms.  PD Dr.   Cornelia   Platzer 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/08/24
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Schwarzkopf D, Meissner W, Wedding U, Riedemann N, Pfeifer R, Fritzenwanger M, Guenther A, Egerland K, Henkel M, Skupin H, Muecke M, Hartog CS. Collaboration and stress in the context of end-of-life decision-making - A survey among nurses and physicians from intensive and palliative care units [Interaktion und Belastung bei Therapiebeschränkungen am Lebensende: Ergebnisse einer Befragung von intensiv- und palliativmedizinischen Pflegekräften und Ärzten]. Z Palliativmed 2012;13:293-300
  •   Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Medicine. 2013;39:1071-1079.
  •   Schwarzkopf D, Westermann I, Skupin H, et al. A novel questionnaire to measure staff perception of end-of-life decision making in the intensive care unit-Development and psychometric testing. J Crit Care 2015; 30:187-195
  •   Hartog CS, Schwarzkopf D, Riedemann NC, et al. End-of-life care in the intensive care unit: A patient-based questionnaire of intensive care unit staff perception and relatives' psychological response. Palliat Med 2015; 29:336-345
  •   Hartog CS, Peschel I, Schwarzkopf D, et al. Are written advance directives helpful to guide end-of-life therapy in the intensive care unit? A retrospective matched-cohort study. J Crit Care 2014; 29:128-133
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.