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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Lung Injury; Respiratory Distress Syndrome, Adult

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Steffen Weber-Carstens, MD; Phone Number: +4930450651055; Email: steffen.weber-carstens@charite.de
    • Principal Investigator: Steffen Weber-Carstens, MD
    • Sub-Investigator: Tobias Wollersheim, MD
    • Sub-Investigator: David Schwaiberger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with ALI

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Steffen Weber-Carstens, MD, Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Extracorporeal Membrane Oxygenation; ARDS,; Pulmonary Ventilation; Nutrition Assessment; ALI,; ECMO,; energy expenditure,; mechanical ventilation,
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: Charité-MEEP-01