Persistent Critical IllnessMetaCO-nonCONCT05026151
Comparing Metabolic Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients
An observational study of Persistent Critical Illness, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
The Corona Virus Disease-19 (COVID-19) pandemic has resulted in an overwhelming number of intensive care (ICU) patient admissions, generally for acute respiratory distress, often resulting in persistent critical illness (PCI). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Persistent Critical Illness
- What is being tested?
- Nutrition therapy according to ICU protocol
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2019to 31 Dec 2021
- How long will I take part?
- 3 Months
- 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 to 95 years
- All sexes
- Adult, Older adult
Study population: Critically ill patients requiring prolonged ICU treatment
Who may be able to join
- adult patients requiring more than 10 days on mechanical ventilation
Who cannot join
- patients refusing use of their coded data
- admission for brain injury or after cardiac arrest
- admission for major burns >20% body surface area (BSA)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital - CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparing Metabolic and Nutrition Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients
The Corona Virus Disease-19 (COVID-19) pandemic has resulted in an overwhelming number of intensive care (ICU) patient admissions, generally for acute respiratory distress, often resulting in persistent critical illness (PCI). Little is known about their metabolic and nutritional characteristics compared to other non-COVID (non-CO) categories of patients.
The aim is to compare the metabolic characteristics and gastro-intestinal function of the previously admitted non-CO and COVID persistent critically ill patients, and the adherence to the ICU nutrition protocol.
Prospective observation study including two consecutive cohorts of PCI, defined by a prolonged mechanical ventilation requirement longer than 10days.
Read the detailed description
The metabolic and nutritional characteristics of the COVID-19 patients requiring prolonged ICU treatment compared to other non-COVID (non-CO) categories of patients remain poorly described. The aim was to compare the metabolic characteristics of the previously admitted non-CO and COVID PCI patients.
Prospective observation study including two consecutive cohorts of PCI, defined as requiring a mechanical ventilation for >10 days.
The comparative cohort is the first patient cohort previously registered as NCT03938961.
Variables: demographic data, severity score (SAPS2, organ failure (SOFA) scores), Nutrition Risk Screening (NRS) score, C-reactive protein (CRP), blood phosphate. Nutritional variables: energy intake (detail of protein, lipids, glucose), fasting time, feeding route, prealbumin values, bowel activity, insulin requirements Outcome: length of mechanical ventilation, ICU and hospital stay and outcome. Descriptive statistics
- Conditions
- Persistent Critical Illness
- Being tested
- Nutrition therapy according to ICU protocol
- Keywords
- Critical care, Metabolism, Nutrition, Propofol sedation, Hypophosphatemia, Refeeding syndrome, Insulin resistance, Malnutrition
- Medical subject headings
- Hypophosphatemia, Refeeding Syndrome, Insulin Resistance, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition therapy according to ICU protocolOther
The study aims a verifying adherence to the ICU nutrition protocol
| Study group | Role | What they receive |
|---|---|---|
| non-CO | Consecutive persistent critically ill patients requiring more than 10 days of mechanical ventilation, admitted just before the first COVID-19 wave Receives: Other: Nutrition therapy according to ICU protocol | |
| COVID | Consecutive persistent critically ill COVID-19 patients requiring more than 10 days of mechanical ventilation, admitted during the first COVID-19 wave Receives: Other: Nutrition therapy according to ICU protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy balance
Delta between energy delivery and prescription
Measured: up to 30 days
Secondary outcomes (5)
Feeding route and time to feeding
Proportion of days on enteral, parenteral, combined, oral feeding or fasting
Measured: up to 30 days
Hypophosphataemia
Number of blood phosphate values <0.8 mmol/l
Measured: up to 30 days
Insulin resistance
Quantity of insulin required to maintain blood glucose with ICU targets
Measured: up to 30 days
Bowel activity
Frequency of diarrhea and constipation
Measured: up to 30 days
Length of ICU and hospital stay
length in days
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Critical IllnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette M Berger, Centre Hospitalier Universitaire Vaudois
- Investigators
- Philippe Eckert, MD, Study chair, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026151
- Sponsor's protocol ID
- CER2020-01453
- Acronym
- MetaCO-nonCO
- Status last verified
- Apr 2022
- First submitted
- 22 Aug 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Metabolic and Nutrition Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05026151
- Acronym / sponsor ID
- MetaCO-nonCO / CER2020-01453
- Conditions
- Persistent Critical Illness
- Keywords
- Critical care, Metabolism, Nutrition, Propofol sedation, Hypophosphatemia, Refeeding syndrome, Insulin resistance, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Aug 2021 (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 Corona Virus Disease-19 (COVID-19) pandemic has resulted in an overwhelming number of intensive care (ICU) patient admissions, generally for acute respiratory distress, often resulting in persistent critical illness (PCI). Little is known about their metabolic and nutritional characteristics compared to other non-COVID (non-CO) categories of patients.
The aim is to compare the metabolic characteristics and gastro-intestinal function of the previously admitted non-CO and COVID persistent critically ill patients, and the adherence to the ICU nutrition protocol.
Prospective observation study including two consecutive cohorts of PCI, defined by a prolonged mechanical ventilation requirement longer than 10days.
Detailed description
The metabolic and nutritional characteristics of the COVID-19 patients requiring prolonged ICU treatment compared to other non-COVID (non-CO) categories of patients remain poorly described. The aim was to compare the metabolic characteristics of the previously admitted non-CO and COVID PCI patients.
Prospective observation study including two consecutive cohorts of PCI, defined as requiring a mechanical ventilation for >10 days.
The comparative cohort is the first patient cohort previously registered as NCT03938961.
Variables: demographic data, severity score (SAPS2, organ failure (SOFA) scores), Nutrition Risk Screening (NRS) score, C-reactive protein (CRP), blood phosphate. Nutritional variables: energy intake (detail of protein, lipids, glucose), fasting time, feeding route, prealbumin values, bowel activity, insulin requirements Outcome: length of mechanical ventilation, ICU and hospital stay and outcome. Descriptive statistics
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-CO | – | Other: Nutrition therapy according to ICU protocolConsecutive persistent critically ill patients requiring more than 10 days of mechanical ventilation, admitted just before the first COVID-19 wave |
| COVID | – | Other: Nutrition therapy according to ICU protocolConsecutive persistent critically ill COVID-19 patients requiring more than 10 days of mechanical ventilation, admitted during the first COVID-19 wave |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients requiring prolonged ICU treatment
Key inclusion criteria (1 listed)
- adult patients requiring more than 10 days on mechanical ventilation
Key exclusion criteria (3 listed)
- patients refusing use of their coded data
- admission for brain injury or after cardiac arrest
- admission for major burns >20% body surface area (BSA)
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 |
|---|---|---|
| Nutrition therapy according to ICU protocolThe study aims a verifying adherence to the ICU nutrition protocol | Other | COVID, non-CO |
Primary outcome
Energy balance
Time frame: up to 30 days
Delta between energy delivery and prescription
5 secondary outcomes
Feeding route and time to feeding
Time frame: up to 30 days
Hypophosphataemia
Time frame: up to 30 days
Insulin resistance
Time frame: up to 30 days
Bowel activity
Time frame: up to 30 days
Length of ICU and hospital stay
Time frame: up to 3 months
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 5 Apr 2022.
- 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.
Philippe Eckert, MD study chair
University of Lausanne
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 Persistent Critical Illness, run by Centre Hospitalier Universitaire Vaudois 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 1 inclusion and 3 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 5 Apr 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 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?
Energy balance (time frame: up to 30 days). 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 5 Apr 2022.