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

Completed

• Conditions: Persistent Critical Illness
• Interventions: Other: Nutrition therapy according to ICU protocol

• Registration Number: NCT05026151
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-30
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID	Nutrition therapy according to ICU protocol	Consecutive persistent critically ill COVID-19 patients requiring more than 10 days of mechanical ventilation, admitted during the first COVID-19 wave
non-CO	Nutrition therapy according to ICU protocol	Consecutive persistent critically ill patients requiring more than 10 days of mechanical ventilation, admitted just before the first COVID-19 wave

Primary Outcome Measures

Name	Time	Method
Energy balance	up to 30 days	Delta between energy delivery and prescription

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lausanne University Hospital - CHUV; 🇨🇭 Lausanne, VD, Switzerland