Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients

Pilot Study of Measuring Energy Expenditure in ECMO Patients Under Consideration of Type of Ventilation and to Approximate Cardiac Output

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01992237

Acronym

MEEP

Enrollment

Registered

2013-11-25

Start date

2013-10-31

Completion date

2018-06-30

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Respiratory Distress Syndrome, Adult

Keywords

ALI,, ARDS,, ECMO,, energy expenditure,, mechanical ventilation,, Extracorporeal Membrane Oxygenation, Nutrition Assessment, Pulmonary Ventilation

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Energy expenditure in kcal	Once within first week after ICU admission for 20 minutes	Measurement of energy expenditure before ECMO use.

Secondary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.

Countries

Germany

Contacts

Primary ContactSteffen Weber-Carstens, MD

steffen.weber-carstens@charite.de+4930450651055

Backup ContactTobias Wollersheim, MD

tobias.wollersheim@charite.de+4930450651808

Outcome results