Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients

NCT01992237 | Unknown DMC

• 1 other identifier: Charité-MEEP-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lung Injury; Respiratory Distress Syndrome, Adult

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Energy expenditure in kcal

  Once during ECMO / ECLA treatment and controlled mechanical ventilation for 20 minutes

• Energy expenditure in kcal

  Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes

• Energy expenditure in kcal

  Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes

• Estimation of cardiac output in liter per minute

  Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay

Other Outcomes (1)

• 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

Study Arms (1)

ALI patients

Patients with ARDS by Berlin definition and with or without clinical indication for ECMO treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ALI

You may qualify if:

• critically ill patients with ALI
• informed consent by the patients or legal proxy

You may not qualify if:

• age \< 18
• no informed consent by the patients or legal proxy
• pregnancy
• infaust prognosis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

Related Publications (3)

• 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.

  PMID: 28143666 RESULT

• Muller MC, Wilke SK, Dobbermann A, Kirsten S, Russ M, Weber-Carstens S, Wollersheim T. Dissolved Oxygen Relevantly Contributes to Systemic Oxygenation During Venovenous Extracorporeal Membrane Oxygenation Support. ASAIO J. 2024 Aug 1;70(8):667-674. doi: 10.1097/MAT.0000000000002171. Epub 2024 Mar 6.

  PMID: 38446867 DERIVED

• Muller MC, Wilke SK, Dobbermann A, Carbon NM, Lammel S, Russ M, Weber-Carstens S, Wollersheim T. Quantitative Gas Exchange in Extracorporeal Membrane Oxygenation-A New Device: Accuracy, Approach-based Difficulties, and Caloric Targeting. ASAIO J. 2023 Jan 1;69(1):61-68. doi: 10.1097/MAT.0000000000001662. Epub 2022 Jan 31.

  PMID: 35759721 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be obtained for metabolomic analyses.

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Steffen Weber-Carstens, MD

  Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffen Weber-Carstens, MD

CONTACT

+4930450651055; steffen.weber-carstens@charite.de

Tobias Wollersheim, MD

CONTACT

+4930450651808; tobias.wollersheim@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Steffen Weber-Carstens

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

DE (1)