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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Unknown status

CT.gov ID

NCT01992237

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Acute Lung Injury Respiratory Distress Syndrome, Adult

Study Design

Study Type:

Observational

Anticipated 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 :

Oct 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
ALI patients Patients with ARDS by Berlin definition and with or without clinical indication for ECMO treatment.

Outcome Measures

Primary Outcome Measures

Energy expenditure in kcal [Once within first week after ICU admission for 20 minutes]
Measurement of energy expenditure before ECMO use.
Energy expenditure in kcal [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.
Energy expenditure in kcal [Once within first week after ECMO /ECLA was removed for 20 minutes]
Measurement of energy expenditure with ECMO / ECLA use.

Secondary Outcome Measures

Energy expenditure in kcal [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.
Energy expenditure in kcal [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.
Energy expenditure in kcal [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.
Estimation of cardiac output in liter per minute [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

Comparing cardiac parameters measured by echo with parameters calculated by right heart catheter [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.