Acute Lung InjuryMEEPNCT01992237
Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients
An observational study of Acute Lung Injury and Respiratory Distress Syndrome, Adult, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Respiratory Distress Syndrome, Adult
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ALI
Who may be able to join
- critically ill patients with ALI
- informed consent by the patients or legal proxy
Who cannot join
- age < 18
- no informed consent by the patients or legal proxy
- pregnancy
- infaust prognosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Steffen Weber-Carstens, MD, +4930450651055, steffen.weber-carstens@charite.de
Steffen Weber-Carstens, MD
About this study
Official title: 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.
- Keywords
- ALI,, ARDS,, ECMO,, energy expenditure,, mechanical ventilation,, Extracorporeal Membrane Oxygenation, Nutrition Assessment, Pulmonary Ventilation
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALI patients | Patients with ARDS by Berlin definition and with or without clinical indication for ECMO treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure in kcal
Measurement of energy expenditure before ECMO use.
Measured: 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.
Measured: Once within first week after ECMO /ECLA treatment started for 20 minutes
Energy expenditure in kcal
Measurement of energy expenditure with ECMO / ECLA use.
Measured: Once within first week after ECMO /ECLA was removed for 20 minutes
Secondary outcomes (4)
Energy expenditure in kcal
Measuring and calculating energy expenditure under consideration of ventilation support for controlled pressure ventilation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Weber-Carstens, Charite University, Berlin, Germany
- Investigators
- Steffen Weber-Carstens, MD, Principal investigator, Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992237
- Sponsor's protocol ID
- Charité-MEEP-01
- Acronym
- MEEP
- Status last verified
- Feb 2017
- First submitted
- 21 Oct 2013
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28143666Muller 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.
PubMed 38446867Muller 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.
PubMed 35759721
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Measuring Energy Expenditure in ECMO Patients Under Consideration of Type of Ventilation and to Approximate Cardiac Output
- ClinicalTrials.gov ID
- NCT01992237
- Acronym / sponsor ID
- MEEP / Charité-MEEP-01
- Keywords
- ALI,, ARDS,, ECMO,, energy expenditure,, mechanical ventilation,, Extracorporeal Membrane Oxygenation, Nutrition Assessment, Pulmonary Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALI patients | – | –Patients with ARDS by Berlin definition and with or without clinical indication for ECMO treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ALI
Key inclusion criteria (2 listed)
- critically ill patients with ALI
- informed consent by the patients or legal proxy
Key exclusion criteria (4 listed)
- age < 18
- no informed consent by the patients or legal proxy
- pregnancy
- infaust prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy expenditure in kcal
Time frame: Once within first week after ICU admission for 20 minutes
Measurement of energy expenditure before ECMO use.
Energy expenditure in kcal
Time frame: 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
Time frame: Once within first week after ECMO /ECLA was removed for 20 minutes
Measurement of energy expenditure with ECMO / ECLA use.
4 secondary outcomes
Energy expenditure in kcal
Time frame: Once during ECMO / ECLA treatment and controlled mechanical ventilation for 20 minutes
Energy expenditure in kcal
Time frame: Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes
Energy expenditure in kcal
Time frame: Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes
Estimation of cardiac output in liter per minute
Time frame: Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 28143666Wollersheim 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.
- Derived from this study: PubMed 38446867Muller 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.
- Derived from this study: PubMed 35759721Muller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Weber-Carstens, MD principal investigator
Charité - Universitätsmedizin Berlin, Department of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Respiratory Distress Syndrome, Adult, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steffen Weber-Carstens, MD (+4930450651055, steffen.weber-carstens@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure in kcal (time frame: Once within first week after ICU admission for 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01992237, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.