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CompletedNCT05026151MetaCO-nonCOUpdated Apr 5, 2022

Comparing Metabolic Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients

An observational study in Persistent Critical Illness, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Centre Hospitalier Universitaire Vaudois · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
18 Years to 95 Years
Sex
All
01

Study 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). 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

02

Conditions studied

  • Persistent Critical Illness

Keywords

  • Critical care
  • Metabolism
  • Nutrition
  • Propofol sedation
  • Hypophosphatemia
  • Refeeding syndrome
  • Insulin resistance
  • Malnutrition
03

In context

Hypophosphatemia

70 studies on the registry are indexed under Hypophosphatemia; 15 are open to participants now.

This study's enrollment of 110 is above the median of 92 across 27 observational studies indexed under Hypophosphatemia.

Browse Hypophosphatemia studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 208 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Critically ill patients requiring prolonged ICU treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients requiring more than 10 days on mechanical ventilation

Exclusion criteria

Exclusion Criteria:

  • patients refusing use of their coded data
  • admission for brain injury or after cardiac arrest
  • admission for major burns >20% body surface area (BSA)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • non-CO

    Consecutive persistent critically ill patients requiring more than 10 days of mechanical ventilation, admitted just before the first COVID-19 wave

    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

    Other: Nutrition therapy according to ICU protocol

Interventions

  • OtherNutrition therapy according to ICU protocol

    The study aims a verifying adherence to the ICU nutrition protocol

06

What researchers measure

Primary outcomes

  1. Energy balance

    Delta between energy delivery and prescription

    Time frame: up to 30 days

Secondary outcomes

  1. Feeding route and time to feeding

    Proportion of days on enteral, parenteral, combined, oral feeding or fasting

    Time frame: up to 30 days

  2. Hypophosphataemia

    Number of blood phosphate values \<0.8 mmol/l

    Time frame: up to 30 days

  3. Insulin resistance

    Quantity of insulin required to maintain blood glucose with ICU targets

    Time frame: up to 30 days

  4. Bowel activity

    Frequency of diarrhea and constipation

    Time frame: up to 30 days

  5. Length of ICU and hospital stay

    length in days

    Time frame: up to 3 months

07

Study locations

1 site
  • Lausanne University Hospital - CHUV
    Lausanne, Canton of Vaud 1011, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Dec 2020, 17 months.

Of 16 observational studies under Hypophosphatemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 17 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2021
First posted
Aug 30, 2021
StartActual
Jul 1, 2019
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2021
Last update
Apr 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05026151
Responsible party
Mette M Berger (Professor Emeritus, Research Staf, Adult Intensive Care Department, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Aug 30, 2021
Start date
Jul 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2021
Last update
Apr 5, 2022

Study contacts

Philippe Eckert, MD
study chair · University of Lausanne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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