NCT06576895

Brief Summary

To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing. The aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

August 14, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

August 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 2, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

August 14, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Intensive CareNutrition

Outcome Measures

Primary Outcomes (9)

  • Nutritional outcomes

    Protein and energy prescription and provision

    Up to day 28 of hospitalization

  • Nutritional outcomes

    Use of Enteral Nutrition (EN)

    Up to day 28 of hospitalization

  • Nutritional outcomes

    Parenteral Nutrition (PN)

    Up to day 28 of hospitalization

  • Nutritional outcomes

    Oral intake and oral nutrition supplements

    Up to day 28 of hospitalization

  • Nutrition service delivery in the ICU and ward setting

    Levels of staffing available and service provision for nutrition care in the ICU and on the ward

    Up to day 28 of hospitalization

  • Descriptions of nutrition prescription, delivery and service variability across ANZ

    Comparison of nutrition care between participating hospitals

    Up to day 28 of hospitalization

  • Patient-centred outcomes

    Duration of hospital stay

    Up to day 28 of hospitalization

  • Patient-centred outcomes

    Mortality

    Up to day 28 of hospitalization

  • Patient-centred outcomes

    Discharge destination

    Up to day 28 of hospitalization

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In a 7 day study period, all adult patients present in the ICU who meet all of the inclusion criteria and no exclusion criteria will be included.

You may qualify if:

  • Age 18 years or older
  • Admitted to ICU after 00:00 on the date of study commencement
  • Remain in ICU for ≥ 48 hours

You may not qualify if:

  • Patients who have been deemed ready to be discharged by the treating team within 48 hours of ICU admission but have not been able to be discharged within 48 hours of ICU admission for logistical reasons (e.g., due to bed unavailability, inability to return home)
  • Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Emma Ridley, A/Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 29, 2024

Study Start

August 26, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 2, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations