Critically IllONCANCT03249051
Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.
A study testing Indirect Calorimetry in people with Critically Ill, run by University of Hohenheim at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Indirect Calorimetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2016to 15 Aug 2017
- Phase
- Interventional
- 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
- Adult, Older adult
Who may be able to join
- age over 18 years
- mechanical ventilation
- an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen
- possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)
- possibility to perform Bioelectrical Impedance Analysis (BIA)
- underlying indication for enteral or/and parenteral nutritional support
- written informed consent from the patient or a legal authorized person
Who cannot join
- cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.
The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.
- Conditions
- Critically Ill
- Being tested
- Indirect Calorimetry
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryOther
Energy need is being determined using indirect Calorimetry
| Study group | Role | What they receive |
|---|---|---|
| Indirect Calorimetry | Experimental | The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition. Receives: Other: Indirect Calorimetry |
| Standard Care | No intervention | This group receives nutrition supply according to the hospital routine ("standard care") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle (PhA)
The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.
Measured: PhA was measured between one and 90 days (during ICU stay)
Secondary outcomes (4)
Nitrogen Balance
Difference between intervention and control group between hospital admission and discharge.
Measured: Nitrogen Balance was measured between one and 90 days (during ICU stay)
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Difference between intervention and control group between hospital admission and discharge.
Measured: ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
Length of hospital stay in days
Difference between intervention and control group between hospital admission and discharge.
Measured: Length of hospital stay was measured between one and 180 days
Length of stay in intensive care unit (ICU) in days
Difference between intervention and control group between hospital admission and discharge.
Measured: Length of ICU stay was measured between one and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start11 Jan 2016
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan C Bischoff, Principal investigator, University of Hohenheim, 70599 Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249051
- Sponsor's protocol ID
- Indirect Calorimetry in ICU
- Acronym
- ONCA
- Status last verified
- Aug 2017
- First submitted
- 25 Jun 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT03249051
- Acronym / sponsor ID
- ONCA / Indirect Calorimetry in ICU
- Conditions
- Critically Ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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.
The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indirect Calorimetry | Experimental | Other: Indirect CalorimetryThe energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition. |
| Standard Care | No intervention | –This group receives nutrition supply according to the hospital routine ("standard care") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age over 18 years
- mechanical ventilation
- an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen
- possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)
- possibility to perform Bioelectrical Impedance Analysis (BIA)
Key exclusion criteria (1 listed)
- cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryEnergy need is being determined using indirect Calorimetry | Other | Indirect Calorimetry |
Primary outcome
Phase angle (PhA)
Time frame: PhA was measured between one and 90 days (during ICU stay)
The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.
4 secondary outcomes
Nitrogen Balance
Time frame: Nitrogen Balance was measured between one and 90 days (during ICU stay)
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Time frame: ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)
Length of hospital stay in days
Time frame: Length of hospital stay was measured between one and 180 days
Length of stay in intensive care unit (ICU) in days
Time frame: Length of ICU stay was measured between one and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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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.
Stephan C Bischoff principal investigator
University of Hohenheim, 70599 Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect Calorimetry in people with Critically Ill, run by University of Hohenheim 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 6 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase angle (PhA) (time frame: PhA was measured between one and 90 days (during ICU stay)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2017.