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Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients (MEEP)

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ClinicalTrials.gov Identifier: NCT01992237
Recruitment Status : Unknown
Verified February 2017 by Steffen Weber-Carstens, Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Steffen Weber-Carstens, Charite University, Berlin, Germany

Brief Summary:
With the perception that lung protective ventilation with regard to low tidal volume ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory distress syndrome) and that the development of new technical devices of extracorporeal lung assist systems with lower complication rates support establishment of lung protective ventilation strategies these systems are more and more frequently used. All critically ill patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and higher mortality risk. Besides inflammation malnutrition is known as one of the main risk factors. Over and underfeeding should be prevented. However nutritional aspects of patients on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in cardiac output and septic state are influencing energy metabolism but until now there is no tool for measuring energy expenditure in clinical routine for patients on ECLA/ECMO. Indirect calorimetry is a simple device only for patients without ECLA/ECMO system. Oxygenation and CO2 (carbon dioxide) elimination by the lung assist system can be calculated but is not implemented to clinical routine. The combination of indirect calorimetry and calculation of lung assist function at the same time would give us the chance to adapt nutrition rates to energy expenditure. This may prevent muscle wasting and weakness. This pilot study will include 40 participating patients during 8 month investigating nutritional therapy adapted to energy expenditure calculated by O2 and CO2 turnover rates in patients on ECLA or ECMO systems. The investigators aim is to describe a calculation to set nutrition targets in ECMO patients. Second the investigators will describe level of nutritional needs under consideration of different mechanical ventilation states. Third O2 consumption and CO2 elimination will be used to estimate cardiac output.

Condition or disease
Acute Lung Injury Respiratory Distress Syndrome, Adult

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of Measuring Energy Expenditure in ECMO Patients Under Consideration of Type of Ventilation and to Approximate Cardiac Output
Study Start Date : October 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : June 2018


Group/Cohort
ALI patients
Patients with ARDS by Berlin definition and with or without clinical indication for ECMO treatment.



Primary Outcome Measures :
  1. Energy expenditure in kcal [ Time Frame: Once within first week after ICU admission for 20 minutes ]
    Measurement of energy expenditure before ECMO use.

  2. Energy expenditure in kcal [ Time Frame: Once within first week after ECMO /ECLA treatment started for 20 minutes ]
    Measurement and calculation of energy expenditure with ECMO / ECLA use and controlled mechanical ventilation.

  3. Energy expenditure in kcal [ Time Frame: Once within first week after ECMO /ECLA was removed for 20 minutes ]
    Measurement of energy expenditure with ECMO / ECLA use.


Secondary Outcome Measures :
  1. Energy expenditure in kcal [ Time Frame: Once during ECMO / ECLA treatment and controlled mechanical ventilation for 20 minutes ]
    Measuring and calculating energy expenditure under consideration of ventilation support for controlled pressure ventilation.

  2. Energy expenditure in kcal [ Time Frame: Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes ]
    Measuring and calculating energy expenditure under consideration of ventilation support. Spontaneous breathing with supportive mechanical ventilation and during ECMO / ECLA treatment.

  3. Energy expenditure in kcal [ Time Frame: Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes ]
    Measuring and calculating energy expenditure under consideration of ECMO /ECLA treatment it self. Spontaneous breathing with supportive mechanical ventilation and during ECMO / ECLA treatment without gas flow just before ECMO / ECLA removal.

  4. Estimation of cardiac output in liter per minute [ Time Frame: Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay ]
    Approximately calculation of cardiac output by O2 and CO2 metabolism and compared to cardiac output measurements by cardiac echo and measurements of thermodilution.


Other Outcome Measures:
  1. Comparing cardiac parameters measured by echo with parameters calculated by right heart catheter [ Time Frame: Calculated from the six measurements of the energy expenditure (as described above) an clinical routine measurements during the ICU stay ]
    If patients get a right heart catheter by clinical reason and echo investigations we will compare these values for equal time-points.


Biospecimen Retention:   Samples With DNA
Whole blood will be obtained for metabolomic analyses.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ALI
Criteria

Inclusion Criteria:

  • critically ill patients with ALI
  • informed consent by the patients or legal proxy

Exclusion Criteria:

  • age < 18
  • no informed consent by the patients or legal proxy
  • pregnancy
  • infaust prognosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992237


Contacts
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Contact: Steffen Weber-Carstens, MD +4930450651055 steffen.weber-carstens@charite.de
Contact: Tobias Wollersheim, MD +4930450651808 tobias.wollersheim@charite.de

Locations
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Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Steffen Weber-Carstens, MD    +4930450651055    steffen.weber-carstens@charite.de   
Principal Investigator: Steffen Weber-Carstens, MD         
Sub-Investigator: Tobias Wollersheim, MD         
Sub-Investigator: David Schwaiberger, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Steffen Weber-Carstens, MD Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine
Publications of Results:
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Responsible Party: Steffen Weber-Carstens, PD Dr. med. Steffen Weber-Carstens, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01992237    
Other Study ID Numbers: Charité-MEEP-01
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Steffen Weber-Carstens, Charite University, Berlin, Germany:
ALI,
ARDS,
ECMO,
energy expenditure,
mechanical ventilation,
Extracorporeal Membrane Oxygenation
Nutrition Assessment
Pulmonary Ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries