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Completed

NCT Number: NCT05026151

Comparing Metabolic 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.

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Key information

Conditions

Persistent Critical Illness Glucose Metabolism Disorders Hyperinsulinism Hypophosphatemia Insulin Resistance Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Refeeding Syndrome

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lausanne University Hospital - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nutrition therapy according to ICU protocol

Other

The study aims a verifying adherence to the ICU nutrition protocol

Primary outcomes

  1. Energy balance

    Time frame: up to 30 days

    Delta between energy delivery and prescription

Secondary outcomes

  1. Feeding route and time to feeding

    Time frame: up to 30 days

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

  2. Hypophosphataemia

    Time frame: up to 30 days

    Number of blood phosphate values <0.8 mmol/l

  3. Insulin resistance

    Time frame: up to 30 days

    Quantity of insulin required to maintain blood glucose with ICU targets

  4. Bowel activity

    Time frame: up to 30 days

    Frequency of diarrhea and constipation

  5. Length of ICU and hospital stay

    Time frame: up to 3 months

    length in days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: MetaCO-nonCO

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 30, 2021
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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