Clinical trial NCT05026151: Comparing Metabolic Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients
Official title: Comparing Metabolic and Nutrition Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Critical Illness
Keywords: Critical care
Metabolism
Nutrition
Propofol sedation
Hypophosphatemia
Refeeding syndrome
Insulin resistance
Malnutrition
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients requiring prolonged ICU treatment

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* adult patients requiring more than 10 days on mechanical ventilation

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)

Primary outcomes:
measure: Energy balance
timeFrame: up to 30 days
Secondary outcomes:
measure: Feeding route and time to feeding
timeFrame: up to 30 days
measure: Hypophosphataemia
timeFrame: up to 30 days
measure: Insulin resistance
timeFrame: up to 30 days
measure: Bowel activity
timeFrame: up to 30 days
measure: Length of ICU and hospital stay
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital - CHUV
state: VD
Study officials:
affiliation: University of Lausanne
name: Philippe Eckert, MD
role: STUDY_CHAIR
References: