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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Persistent Critical Illness

Intervention / Treatment
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* Other: Nutrition therapy according to ICU protocol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-CO<br>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<br>* The study aims a verifying adherence to the ICU nutrition protocol<br>|
| COVID<br>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<br>* The study aims a verifying adherence to the ICU nutrition protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy balance | Delta between energy delivery and prescription | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding route and time to feeding | Proportion of days on enteral, parenteral, combined, oral feeding or fasting | up to 30 days | 
| Hypophosphataemia | Number of blood phosphate values <0.8 mmol/l | up to 30 days | 
| Insulin resistance | Quantity of insulin required to maintain blood glucose with ICU targets | up to 30 days | 
| Bowel activity | Frequency of diarrhea and constipation | up to 30 days | 
| Length of ICU and hospital stay | length in days | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refeeding syndrome, Critical care, Metabolism, Nutrition, Propofol sedation, Hypophosphatemia, Insulin resistance, Malnutrition