Clinical trial NCT01992237: Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients
Official title: Pilot Study of Measuring Energy Expenditure in ECMO Patients Under Consideration of Type of Ventilation and to Approximate Cardiac Output
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Respiratory Distress Syndrome, Adult
Keywords: ALI,
ARDS,
ECMO,
energy expenditure,
mechanical ventilation,
Extracorporeal Membrane Oxygenation
Nutrition Assessment
Pulmonary Ventilation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ALI

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.


Eligibility 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

Primary outcomes:
measure: Energy expenditure in kcal
timeFrame: Once within first week after ICU admission for 20 minutes
measure: Energy expenditure in kcal
timeFrame: Once within first week after ECMO /ECLA treatment started for 20 minutes
measure: Energy expenditure in kcal
timeFrame: Once within first week after ECMO /ECLA was removed for 20 minutes
Secondary outcomes:
measure: Energy expenditure in kcal
timeFrame: Once during ECMO / ECLA treatment and controlled mechanical ventilation for 20 minutes
measure: Energy expenditure in kcal
timeFrame: Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes
measure: Energy expenditure in kcal
timeFrame: Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes
measure: Estimation of cardiac output in liter per minute
timeFrame: Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay
Other outcomes:
measure: Comparing cardiac parameters measured by echo with parameters calculated by right heart catheter
timeFrame: Calculated from the six measurements of the energy expenditure (as described above) an clinical routine measurements during the ICU stay
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine
name: Steffen Weber-Carstens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wollersheim T, Frank S, Muller MC, Skrypnikov V, Carbon NM, Pickerodt PA, Spies C, Mai K, Spranger J, Weber-Carstens S. Measuring Energy Expenditure in extracorporeal lung support Patients (MEEP) - Protocol, feasibility and pilot trial. Clin Nutr. 2018 Feb;37(1):301-307. doi: 10.1016/j.clnu.2017.01.001. Epub 2017 Jan 16.