AzTrials
AzTrials

Nutritional DisorderPhase 3EFFORTcomboNCT04012333

The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial

A Phase 3 study testing OLIMEL 7,6%E / PeriOLIMEL 2,5%E in people with Nutritional Disorder and Critical Illness, run by RWTH Aachen University at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OLIMEL 7,6%E / PeriOLIMEL 2,5%E
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteGermany
Study dates
Jun 2020to Mar 2022
Phase
Phase 3
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

Who may be able to join

  • ≥18 years old;
  • Expected to remain mechanically ventilated for an additional 48 hours from screening;
  • And have one or more of the following risk factors that make them at high nutritional risk:
  • Low (≤25) or High BMI (≥35)
  • Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
  • Frailty (Clinical Frailty Scale 5 or more from proxy)
  • Sarcopenia (SARC-F score of 4 or more from proxy)
  • From point of screening, projected duration of mechanical ventilation >4 days

Who cannot join

  • >96 continuous hours of mechanical ventilation before enrollment
  • Expected death or withdrawal of life-sustaining treatments within 7 days from screening
  • Pregnancy
  • The responsible clinician feels that the patient either needs low or high protein
  • Absolute contraindication to EN
  • Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia.
Show all 14Show fewer
  • Severe chronic liver disease (MELD-score >20) or acute fulminant hepatitis.
  • Metabolic disorders involving impaired nitrogen utilization
  • Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted)
  • Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)
  • Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
  • Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)
  • Intracranial or spinal process affecting motor function
  • Patients in hospital >5 days prior to ICU admission

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

Other trials in Germany

About this study

The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional recovery as measured by 6-minute walk distance just prior to hospital discharge? The hypothesis: Compared to a control group reflective of usual care prescribing practices and an EN only approach, the administration of a higher dose protein/amino acids using EN and PN to nutritionally high-risk critically ill patients will be associated with improved functional outcome.

Read the detailed description

Positive, neutral, or negative, the results of the EFFORTcombo study will inform the clinical practice in ICU settings around the world. If positive, because of the pragmatic, multicentre nature of this trial, results will be broadly applicable to all critically ill patients worldwide. If the results are negative, it will be ensured that patients no longer receive high-dose protein/amino acid admixtures or possibly, combined EN/PN.

As it relates to critical care nutrition practice in general, there is a long history of practice-changing initiatives. A process of synthesizing (in the form of evidence-based clinical practice guidelines) and disseminating best practice ideas (in the form of web-based repository of tools and information [see www.criticalcarenutrition.com]) was established.

Over the past several years, this program of research with leaders of the American Society of Parenteral and Enteral Nutrition (ASPEN) and this specific protocol at the annual Clinical Nutrition Week with society leaders, researchers, and the clinical nutrition community at large has been discussed. Partnership with ASPEN will further facilitate both, recruitment initiatives and, importantly, the knowledge translation initiatives. These efforts will increase the likelihood of the uptake of EFFORT results across the world.

This study has both the potential to answer a high-priority clinical question and also transform the new approach in clinical nutrition research. It further represents a unique collaboration between ASPEN, its global partners, and the Clinical Evaluation Research Unit, a methodological support center based in Kingston, Ontario, Canada and managed by Dr. Daren Heyland. If successful, this type of collaboration sets an important precedent for how this community may approach additional research questions related to clinical nutrition. Nested within this larger volunteer-driven registry trial, the aim is to complete a significant sub-study that will establish the role of combined EN/PN in these nutritionally high-risk patients. This protocol pertains to the specifics of this sub-study of combined EN/PN. At the end of the trial, the data from this sub-study will be merged into the results of the overall parent EFFORT Trial (where data points are similar).

Being tested
OLIMEL 7,6%E / PeriOLIMEL 2,5%E
Medical subject headings
Nutrition Disorders, Critical Illness, Malnutrition, Frailty, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OLIMEL 7,6%E / PeriOLIMEL 2,5%EDrug

    OLIMEL 7,6%E will be administered via a central access whereas PeriOLIMEL 2,5%E will be administered peripherally.

Study groups in NCT04012333
Study groupRoleWhat they receive
InterventionExperimentalPatients will receive standard care plus OLIMEL 7,6%E or if no central venous access available PeriOLIMEL 2,5%E to reach protein targets: >2.2g/kg/day
Receives: Drug: OLIMEL 7,6%E / PeriOLIMEL 2,5%E
Standard CareNo interventionPatients will receive standard care (enteral nutrition only) to stay below the protein level: <1.2g/kg/day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-minute walking distance

    measured by performing a 6-minute walking test

    Measured: at hospital discharge, up to 12 weeks

Secondary outcomes (13)

  1. Overall strength-upper and lower extremity

    MRC sum-score

    Measured: at hospital discharge, up to 12 weeks

  2. Quadriceps force-lower extremity strength

    Hand held dynamometry

    Measured: ICU and at hospital discharge, up to 12 weeks

  3. Distal strength-hand grip strength

    Hand grip dynamometry

    Measured: ICU and at hospital discharge, up to 12 weeks

  4. Overall Physical Functional status

    Walking Impairment Questionnaire

    Measured: Baseline (questionnaire only) and SPPB & FSS- ICU at ICU and at hospital discharge, up to 12 weeks

  5. Overall Physical Functional status

    FSS-ICU

    Measured: Baseline (questionnaire only) and SPPB & FSS- ICU at ICU and at hospital discharge, up to 12 weeks

  6. Overall Physical Functional status

    SPPB

    Measured: Baseline (questionnaire only) and SPPB & FSS- ICU at ICU and at hospital discharge, up to 12 weeks

  7. Discharge location

    Discharge location

    Measured: at hospital discharge, up to 12 weeks

  8. Body composition

    Ultrasound of quadriceps

    Measured: Enrollment, ICU day 10 and at hospital discharge, up to 12 weeks

  9. Body composition (when clinically available)

    Abdominal CT scan at 3rd lumbar vertebra

    Measured: Only when clinically available, from 2 weeks before enrolment until 2 weeks after enrolment

  10. Health-related quality of life

    SF-36

    Measured: (Telephone) survey at baseline and 6 months

  11. Physical functioning

    Katz ADL

    Measured: (Telephone) survey at hospital discharge, up to 12 weeks and 6 months

  12. Health-related quality of life

    EQ-5D-5L

    Measured: (Telephone) survey at 6 months

  13. Physical functioning

    Lawton IADL

    Measured: (Telephone) survey at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2019
  2. Study startJun 2020 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2022 (estimated)

Why it stopped: PI left site

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention: enteral and parenteral nutrition to reach protein target of 2.2g/kg/day Control: only enteral nutrition to stay below protein target of 1.2g/kg/day
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04012333
Sponsor's protocol ID
18-108
Acronym
EFFORTcombo
Status last verified
Oct 2022
First submitted
3 Jul 2019
Last updated
27 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hill A, Heyland DK, Elke G, Schaller SJ, Stocker R, Haberthur C, von Loeffelholz C, Suchner U, Puthucheary ZA, Bear DE, Ney J, Clasen KC, Meybohm P, Lindau S, Laurentius T, Stoppe C. Meeting nutritional targets of critically ill patients by combined enteral and parenteral nutrition: review and rationale for the EFFORTcombo trial. Nutr Res Rev. 2020 Dec;33(2):312-320. doi: 10.1017/S0954422420000165. Epub 2020 Jul 16.

    PubMed 32669140

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OLIMEL 7,6%E / PeriOLIMEL 2,5%E in people with Nutritional Disorder and Critical Illness, run by RWTH Aachen University 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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 27 Oct 2022. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walking distance (time frame: at hospital discharge, up to 12 weeks). 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 NCT04012333, which also lists 1 linked publication.

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 27 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in