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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01992237
Other study ID # Charité-MEEP-01
Secondary ID
Status Recruiting
Phase N/A
First received October 21, 2013
Last updated February 7, 2017
Start date October 2013
Est. completion date June 2018

Study information

Verified date February 2017
Source Charite University, Berlin, Germany
Contact Steffen Weber-Carstens, MD
Phone +4930450651055
Email steffen.weber-carstens@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Wollersheim T, Frank S, Müller 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. 2017 Ja — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Comparing cardiac parameters measured by echo with parameters calculated by right heart catheter If patients get a right heart catheter by clinical reason and echo investigations we will compare these values for equal time-points. Calculated from the six measurements of the energy expenditure (as described above) an clinical routine measurements during the ICU stay
Primary Energy expenditure in kcal Measurement of energy expenditure before ECMO use. Once within first week after ICU admission for 20 minutes
Primary Energy expenditure in kcal Measurement and calculation of energy expenditure with ECMO / ECLA use and controlled mechanical ventilation. Once within first week after ECMO /ECLA treatment started for 20 minutes
Primary Energy expenditure in kcal Measurement of energy expenditure with ECMO / ECLA use. Once within first week after ECMO /ECLA was removed for 20 minutes
Secondary Energy expenditure in kcal Measuring and calculating energy expenditure under consideration of ventilation support for controlled pressure ventilation. Once during ECMO / ECLA treatment and controlled mechanical ventilation for 20 minutes
Secondary Energy expenditure in kcal Measuring and calculating energy expenditure under consideration of ventilation support. Spontaneous breathing with supportive mechanical ventilation and during ECMO / ECLA treatment. Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes
Secondary Energy expenditure in kcal 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. Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes
Secondary Estimation of cardiac output in liter per minute Approximately calculation of cardiac output by O2 and CO2 metabolism and compared to cardiac output measurements by cardiac echo and measurements of thermodilution. Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay
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