Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013672

Trial Description

start of 1:1-Block title

Title

Indication and outcome of decompressive laparotomy for abdominal compartment syndrome under extracorporeal membrane oxygenation

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

Trial Acronym

ECMO DL

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

In the last decades, extracorporeal membrane oxygenation is increasingly used on intensive care units. Indications are respiratory failure, support of cardiogenic shock and extracorporeal cardiopulmonary resuscitation. A potential complication of critical care patients is the adbominal compartment syndrome, in which the abdominal pressure increases, inhibiting mechanical ventilation and possibly leading to cardiac arrest. The treatment for abdominal compartment syndrome is opening the adbomen (so called decompressive laparotomy) to lower the intraadbominal pressure. Abdominal compartment syndrome is a frequent complication under extracorporeal membrane oxygenation. Risk factors and outcome are not observed to date on adult patients.

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

Brief Summary in Scientific Language

Utilisation of ECMO has increased in the last decades. Abdominal compartment syndrome can complicate the clinical course of ECMO patients. Regularly, a bedside decompressive laparotomy (DL) is undertaken. Mortality for ECMO itself, as for DL is high. Risk factors for the development of abdominal compartment syndrome under ECMO therapy and the outcome of DL under ECMo is not examined to date on an adult cohort. For our analysis we observe all ECMO patients during a 2,5 year intervall concerning indications, risk factors and outcome.

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

Organizational Data

  •   DRKS00013672
  •   2018/01/10
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   267/17, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   R19.8 -  Other specified symptoms and signs involving the digestive system and abdomen
  •   J80.0 -  [generalization J80: Adult respiratory distress syndrome]
  •   I21.9 -  Acute myocardial infarction, unspecified
  •   I25.1 -  Atherosclerotic heart disease
  •   I08.9 -  Multiple valve disease, unspecified
  •   I27.9 -  Pulmonary heart disease, unspecified
  •   I26 -  Pulmonary embolism
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Retrospective analysis of our anonymized ECMO--database. ECMO without DL. Observed parameters: age, gender, body mass index, total hospital stay, hospital stay post-ECMO, hospital stay post-DL, Intensive care unit (ICU) stay, ICU stay post-ECMO, ICU-stay post-DL, ECMO start, duration of ECMO therapy, use of a left-ventricular assist device, CPR pre-ECMO, ECMO-mode (veno-venous/veno-arterial), time of DL, duration of ECMo until DL, diagnosis for ECMO, blood gas analysis of DL-patients pre and post DL, flow on ECMO pre and post DL, fluid balance 24 h before DL, Simplified Acute Physiology Score (SAPS) II on ICU admission and ECMO-start, Therapeutic Intervention Scoring System (TISS) on ICU-admission and ECMO-start, Charlson Comorbidity Index
  •   Retrospective analysis of our anonymized ECMO--database. ECMO with DL. Observed parameters: age, gender, body mass index, total hospital stay, hospital stay post-ECMO, hospital stay post-DL, Intensive care unit (ICU) stay, ICU stay post-ECMO, ICU-stay post-DL, ECMO start, duration of ECMO therapy, use of a left-ventricular assist device, CPR pre-ECMO, ECMO-mode (veno-venous/veno-arterial), time of DL, duration of ECMo until DL, diagnosis for ECMO, blood gas analysis of DL-patients pre and post DL, flow on ECMO pre and post DL, fluid balance 24 h before DL, Simplified Acute Physiology Score (SAPS) II on ICU admission and ECMO-start, Therapeutic Intervention Scoring System (TISS) on ICU-admission and ECMO-start, Charlson Comorbidity Index
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Mortality of ACS treated with DL under ECMO

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

Secondary Outcome

Hospital stay, ICU stay, risk factors (mortality, DL)

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
  •   2017/09/01
  •   175
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

ECMO-therapy on adult patients independent of underlying diagnosis between 03/2014 and 09/2016

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

Exclusion Criteria

Age under 18 years

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum BonnKlinik- und Poliklinik für Allgemein- Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  PD Dr. med.  Tim  Glowka 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • 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
    • Universitätsklinikum BonnKlinik- und Poliklinik für Allgemein- Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  PD Dr. med.  Tim  Glowka 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • 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
    • Universitätsklinikum BonnKlinik- und Poliklinik für Allgemein- Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  PD Dr. med.  Tim  Glowka 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • 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
    • Universitätsklinikum BonnKlinik- und Poliklinik für Allgemein- Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  PD Dr. med.  Tim  Glowka 
    • Sigmund-Freud-Str. 25
    • 53105  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/10/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfprotokoll
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.