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

NCT05026151 | Completed

• 1 other identifier: CER2020-01453
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Energy balance

  Delta between energy delivery and prescription

  up to 30 days

Secondary Outcomes (5)

• Feeding route and time to feeding

  up to 30 days

• Hypophosphataemia

  up to 30 days

• Insulin resistance

  up to 30 days

• Bowel activity

  up to 30 days

• Length of ICU and hospital stay

  up to 3 months

Study Arms (2)

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

Nutrition therapy according to ICU protocol OTHER

The study aims a verifying adherence to the ICU nutrition protocol

COVID; non-CO

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients requiring prolonged ICU treatment

You may qualify if:

• adult patients requiring more than 10 days on mechanical ventilation

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Lausanne University Hospital - CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Hypophosphatemia; Refeeding Syndrome; Insulin Resistance; Malnutrition

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Philippe Eckert, MD

  University of Lausanne

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus, Research Staf, Adult Intensive Care Department

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 30, 2021
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)