Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)NAChONCT02839018
Nutrient Pattern Analysis in Critically Ill Patients (NAChO)
An observational study of Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Muscle Weakness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Little is known about nutritional Parameters that potentially influence the course of intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Muscle Weakness
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2017to 20 Mar 2020
- 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: critically ill patients with severe Sepsis/shock ("Sepsis Group") or intracerebral conditions (CNS Group)
Who may be able to join
- Age ≥18 years
- Written informed consent obtained from the patient's legal representative and later from the patients (as soon as possible)
- Individuals diagnosed with severe head trauma or intracerebral hemorrhage ("central nervous system group") or with severe sepsis/ septic shock ("Sepsis group") at any time from ICU admission until day 5 (i.e. day of screening)
- Patient on the ICU for ≥ 5 days ("ICU long stayer")
Who cannot join
- Language other than German or French
- Institutionalized Individuals (e.g. prisoners, severe pre-existing mental incapacity)
- Patients with known pre-existing neurological or psychiatric disease that will make informed consent likely impossible
- Patients with known pregnancy or known to be lactating will not be included to the investigation. Due to the observational/ diagnostical nature of the study, a pregnancy test will not be performed.
- Patients on extracorporeal membrane oxygenation (ECMO)
- Clinical signs of pre-existing malnutrition (Body mass index <18)
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- Pre-existing evidence for history of anorexia or bulimia
- Parenteral nutrition received within last 5 days (for more than 12 hours) or evidence for parental nutrition needed within next 7 days
- Terminal disease (i.e. life expectancy <14 days)
- Patients with active malignancy
- Patients on biologicals interfering with metabolism (e.g. infliximab)
- Patients on chronic steroid medication (i.e. prednisone equivalent dose >10mg/day)
- Patients on neuromuscular blocking agents on a regular basis (i.e. on a repetitive basis within last 48 hours or evidence for need within next 7 days)
- At screening (day 5): prescribed caloric intake substantially higher (i.e. > 150% of caloric need of indirect calorimetry) than indirect calorimetric results (in intubated patients) or i.e. standard-of-care (25 Kcal/kg body weight/day)
- Severe adipositas defined as BMI >40
- Known pre-existing allergy to standard enteral formulae
- Subject previously enrolled to an interventional trial that is not considered standard-of-care (e.g. investigation of new medication/drug or medical devices)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrient Pattern Analysis in Critically Ill Patients Using Omics Technology (NAChO): A Prospective Single-center Observational Trial
Little is known about nutritional Parameters that potentially influence the course of intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk.
- Medical subject headings
- Muscle Weakness
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 |
|---|---|---|
| Central nervous system (CNS) group | n=50 patients with presumed low prevalence of ICU-AW | |
| Severe sepsis/shock group | n=50 patients with presumed high prevalence of ICU-AW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in blood nutrient levels over time in patients with/without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.
Measured: days 6 to 14
Differences in blood nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.
Measured: days 6 to 14
Secondary outcomes (3)
Differences in urine nutrient levels over time in patients with/ without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.
Measured: days 6 to 14
Differences in urine nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.
Measured: days 6 to 14
Subgroup analysis: differences in nutrient levels at day 14 vs. day 6 in muscle biopsy samples of ICU long stayer patients in study groups (i.e. "ICU-AW" vs. "no-ICU-AW" and "Sepsis" vs. "CNS").
Measured: days 6 to 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Nestec Ltd.
- Responsible party
- Sponsor
- Investigators
- Joerg C Schefold, MD, Principal investigator, Inselspital, Bern University HospitalJukka Takala, MD, Study chair, Inselspital, Bern University HospitalStephan M Jakob, MD, Study chair, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839018
- Sponsor's protocol ID
- NAChO
- Acronym
- NAChO
- Status last verified
- Mar 2020
- First submitted
- 18 Jul 2016
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrient Pattern Analysis in Critically Ill Patients Using Omics Technology (NAChO): A Prospective Single-center Observational Trial
- ClinicalTrials.gov ID
- NCT02839018
- Acronym / sponsor ID
- NAChO / NAChO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Nestec Ltd.
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 20 Jul 2016 (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.
Little is known about nutritional Parameters that potentially influence the course of intensive-care unit acquired weakness (ICU - AW). The investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central nervous system (CNS) group | – | –n=50 patients with presumed low prevalence of ICU-AW |
| Severe sepsis/shock group | – | –n=50 patients with presumed high prevalence of ICU-AW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients with severe Sepsis/shock ("Sepsis Group") or intracerebral conditions (CNS Group)
Key inclusion criteria (4 listed)
- Age ≥18 years
- Written informed consent obtained from the patient's legal representative and later from the patients (as soon as possible)
- Individuals diagnosed with severe head trauma or intracerebral hemorrhage ("central nervous system group") or with severe sepsis/ septic shock ("Sepsis group") at any time from ICU admission until day 5 (i.e. day of screening)
- Patient on the ICU for ≥ 5 days ("ICU long stayer")
Key exclusion criteria (17 listed)
- Language other than German or French
- Institutionalized Individuals (e.g. prisoners, severe pre-existing mental incapacity)
- Patients with known pre-existing neurological or psychiatric disease that will make informed consent likely impossible
- Patients with known pregnancy or known to be lactating will not be included to the investigation. Due to the observational/ diagnostical nature of the study, a pregnancy test will not be performed.
- Patients on extracorporeal membrane oxygenation (ECMO)
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
Differences in blood nutrient levels over time in patients with/without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.
Time frame: days 6 to 14
Differences in blood nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.
Time frame: days 6 to 14
3 secondary outcomes
Differences in urine nutrient levels over time in patients with/ without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6.
Time frame: days 6 to 14
Differences in urine nutrient levels over time in patients in "sepsis group" vs. "CNS group". Primary comparison of interest is between day 14 vs. day 6.
Time frame: days 6 to 14
Subgroup analysis: differences in nutrient levels at day 14 vs. day 6 in muscle biopsy samples of ICU long stayer patients in study groups (i.e. "ICU-AW" vs. "no-ICU-AW" and "Sepsis" vs. "CNS").
Time frame: days 6 to 14
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 23 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Joerg C Schefold, MD principal investigator
Inselspital, Bern University Hospital
Jukka Takala, MD study chair
Inselspital, Bern University Hospital
Stephan M Jakob, MD study chair
Inselspital, Bern University Hospital
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 Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Muscle Weakness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 17 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 23 Mar 2020. 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 Switzerland. 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?
Differences in blood nutrient levels over time in patients with/without ICU-AW (i.e. "ICU-AW group" vs. "no-ICU-AW group". Primary comparison of interest is between day 14 vs. day 6. (time frame: days 6 to 14). The study lists 2 primary outcomes in all. 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 23 Mar 2020.