NCT06244381

Brief Summary

This study aims to evaluate the efficiency of the urea/creatinine ratio as a catabolism marker compared to indirect calorimetry to optimize nutritional support in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 29, 2024

Last Update Submit

February 16, 2025

Conditions

Critically Ill

Keywords

CatabolismIndirect calorimetryUrea/creatinine ratioCritically illCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Urea/creatinine ratio

    Compare urea/creatinine ratio with indirect calorimetry to determine catabolism and optimize nutritional support in critically ill COVID-19 patients.

    30 days

Secondary Outcomes (3)

  • Serum albumin

    30 days

  • Hemoglobin concentration

    30 days

  • C-reactive protein

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Twenty critically ill COVID-19 patients admitted to a 35-bed ICU intended for patients with COVID-19 from April to August 2021 and who underwent determination of energy expenditure with indirect calorimetry on days 1, 4, 7, 9, 14, 17, and 20 days after admission, and who did not have serum creatinine \> 4.0 mg/dL upon admission, were not chronic dialysis patients and did not undergo dialysis treatment during the study period. The urea, creatinine, C-reactive protein, hemoglobin, and albumin results will be obtained from the hospital's electronic medical record during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Domingos

São Luiz, Maranhão, 65075775, Brazil

Location

Related Publications (6)

  • Singer P, Blaser AR, Berger MM, Calder PC, Casaer M, Hiesmayr M, Mayer K, Montejo-Gonzalez JC, Pichard C, Preiser JC, Szczeklik W, van Zanten ARH, Bischoff SC. ESPEN practical and partially revised guideline: Clinical nutrition in the intensive care unit. Clin Nutr. 2023 Sep;42(9):1671-1689. doi: 10.1016/j.clnu.2023.07.011. Epub 2023 Jul 15.

    PMID: 37517372RESULT

  • Long CL, Dillard DR, Bodzin JH, Geiger JW, Blakemore WS. Validity of 3-methylhistidine excretion as an indicator of skeletal muscle protein breakdown in humans. Metabolism. 1988 Sep;37(9):844-9. doi: 10.1016/0026-0495(88)90118-7.

    PMID: 3138511RESULT

  • Haines RW, Zolfaghari P, Wan Y, Pearse RM, Puthucheary Z, Prowle JR. Elevated urea-to-creatinine ratio provides a biochemical signature of muscle catabolism and persistent critical illness after major trauma. Intensive Care Med. 2019 Dec;45(12):1718-1731. doi: 10.1007/s00134-019-05760-5. Epub 2019 Sep 17.

    PMID: 31531715RESULT

  • Niederer LE, Miller H, Haines KL, Molinger J, Whittle J, MacLeod DB, McClave SA, Wischmeyer PE. Prolonged progressive hypermetabolism during COVID-19 hospitalization undetected by common predictive energy equations. Clin Nutr ESPEN. 2021 Oct;45:341-350. doi: 10.1016/j.clnesp.2021.07.021. Epub 2021 Aug 3.

    PMID: 34620338RESULT

  • Long CL, Schaffel N, Geiger JW, Schiller WR, Blakemore WS. Metabolic response to injury and illness: estimation of energy and protein needs from indirect calorimetry and nitrogen balance. JPEN J Parenter Enteral Nutr. 1979 Nov-Dec;3(6):452-6. doi: 10.1177/014860717900300609.

    PMID: 575168RESULT

  • Monk DN, Plank LD, Franch-Arcas G, Finn PJ, Streat SJ, Hill GL. Sequential changes in the metabolic response in critically injured patients during the first 25 days after blunt trauma. Ann Surg. 1996 Apr;223(4):395-405. doi: 10.1097/00000658-199604000-00008.

    PMID: 8633918RESULT

MeSH Terms

Conditions

Critical IllnessCOVID-19

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • JOSE AZEVEDO, MD, PhD

    Hospital São Domingos

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 6, 2024

Study Start

March 1, 2024

Primary Completion

June 30, 2024

Study Completion

October 1, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)