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

NCT ID: NCT05026151

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-31

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

Conditions

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Persistent Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-CO

Consecutive persistent critically ill patients requiring more than 10 days of mechanical ventilation, admitted just before the first COVID-19 wave

Nutrition therapy according to ICU protocol

Intervention Type OTHER

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

Nutrition therapy according to ICU protocol

Intervention Type OTHER

The study aims a verifying adherence to the ICU nutrition protocol

Interventions

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Nutrition therapy according to ICU protocol

The study aims a verifying adherence to the ICU nutrition protocol

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Mette M Berger

Professor Emeritus, Research Staf, Adult Intensive Care Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Eckert, MD

Role: STUDY_CHAIR

University of Lausanne

Locations

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Lausanne University Hospital - CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CER2020-01453

Identifier Type: -

Identifier Source: org_study_id

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