Comparing Metabolic Characteristics of Persistent Critically Ill Non-COVID and COVID-19 Patients (MetaCO-nonCO)

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.

Study Overview

• Status: Completed
• Conditions: Persistent Critical Illness
• Intervention / Treatment: Other: Nutrition therapy according to ICU protocol

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Lausanne university hospital - CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients requiring prolonged ICU treatment

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The study aims a verifying adherence to the ICU nutrition 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; The study aims a verifying adherence to the ICU nutrition protocol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Study Chair: Philippe Eckert, MD, Université de Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Insulin resistance; Nutrition; Critical care; Malnutrition; Metabolism; Hypophosphatemia; Propofol sedation; Refeeding syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CER2020-01453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No