NCT07412366

Brief Summary

Urea-to-Creatinine Ratio as a Marker of Metabolic Transition in Septic Shock: A Comparison with Indirect Calorimetry. This study investigates whether the urea-to-creatinine ratio can serve as a simple marker of metabolic state in patients with septic shock. Septic shock is associated with hypermetabolism and severe protein catabolism, which worsen outcomes. Although indirect calorimetry is the gold standard for measuring energy expenditure and metabolic demand in critically ill patients, its availability in ICUs is limited. The authors hypothesize that the urea-to-creatinine ratio reflects protein catabolism and correlates with energy expenditure measured by indirect calorimetry, making it a potential tool to identify the transition from the catabolic to the anabolic phase and to guide nutritional therapy. The primary objective is to assess the correlation between the urea-to-creatinine ratio and energy expenditure in septic shock patients. Secondary objectives include evaluating changes in systemic inflammation over time using C-reactive protein (CRP). This is a prospective observational cohort study of adult patients with septic shock admitted to a medical-surgical ICU who require at least three days of mechanical ventilation and undergo indirect calorimetry. Energy expenditure will be measured at predefined intervals during the ICU stay, while urea, creatinine, and CRP levels will be collected regularly. Patients with severe renal dysfunction, renal replacement therapy, or high oxygen requirements will be excluded. Data will be analyzed across three time periods during mechanical ventilation to examine trends in energy expenditure, urea-to-creatinine ratio, and inflammation. Demographic and clinical variables will also be collected. The study aims to determine whether changes in the urea-to-creatinine ratio mirror metabolic transitions detected by indirect calorimetry, potentially offering a practical alternative for metabolic monitoring in septic shock patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Apr 2026

Status
not yet recruiting

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

Study Progress10%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Septic Shock

Keywords

urea-to-creatinine ratioIndirect calorimetrySeptic shockICUCatabolism

Outcome Measures

Primary Outcomes (1)

  • Urea-to-creatinine ratio and energy expenditure measured by indirect calorimetry

    To evaluate the correlation between the urea-to-creatinine ratio and energy expenditure measured by indirect calorimetry in patients with septic shock, in order to identify the transition from the catabolic to the anabolic phase. Urea and creatinine will be determined on days 1,4,7,11, 14,17 and 20. In the same period patients will be submmited to determination of energy expenditure by indirect calorimetry using the E-COVX module integrated into the Carescape B650 monitor (GE Healthcare, Helsinki, Finland).

    20 days

Secondary Outcomes (1)

  • C-reactive protein (CRP)

    20 days

Study Arms (1)

Septic shock patients

Patients will be submmited to determinations os indirect calorimetry and urea-to-creatinine ratio on days 1, 4, 7, 11, 14, 17 and 20

Eligibility Criteria

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

Adult patients with septic shock, defined according to Sepsis-3 criteria, admitted to a 53-bed medical-surgical intensive care unit between April 2026 and March 2027. Eligible patients will be required to have undergone invasive mechanical ventilation for at least three consecutive days and to have had energy expenditure measured by indirect calorimetry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 8633918BACKGROUND

  • Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

    PMID: 26903338BACKGROUND

  • Paulus MC, Melchers M, van Es A, Kouw IWK, van Zanten ARH. The urea-to-creatinine ratio as an emerging biomarker in critical care: a scoping review and meta-analysis. Crit Care. 2025 May 2;29(1):175. doi: 10.1186/s13054-025-05396-6.

    PMID: 40317012RESULT

  • 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

  • Israfilov E, Kir S. Comparison of Energy Expenditure in Mechanically Ventilated Septic Shock Patients in Acute and Recovery Periods via Indirect Calorimetry. JPEN J Parenter Enteral Nutr. 2021 Sep;45(7):1523-1531. doi: 10.1002/jpen.2063. Epub 2021 Feb 16.

    PMID: 33314315RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • JOSE AZEVEDO, MD, PhD

    Hospital Sao Domingos

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JOSE AZEVEDO, MD, PhD

CONTACT

+55 98 991375595jrazevedo47@gmail.com

JOAMMA QUARIGUASI, MD

CONTACT

+55 98 98418-6565joamaq@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share