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Critical IllnessNCT07240103

Blood-Interstitial Fluid Glucose Gap

An observational study of Critical Illness and Metabolism Disorders, run by Chinese Medical Association at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Critical Illness, Metabolism Disorders
How many people
140 participants
Where
1 siteChina
Study dates
13 Jul 2023to 1 Oct 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: critically ill patient

Who may be able to join

  • Age≥ 18 years and < 80 years
  • ICU stay ≤48 hours
  • Expected ICU stay > 24 hours
  • APACHE II score≥ 8

Who cannot join

  • local infection within the sensor placement area
  • Laparotomy within lower abdomen
  • Participated in this study before
  • In other clinical trails

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: Blood-Interstitial Fluid Glucose Gap: A Novel Indicator for Assessing Metabolic Status and Mortality Risk in Critically Ill Patients

Metabolic monitoring is fundamental to guiding nutritional therapy in critically ill patients. Although indirect calorimetry is the established gold standard for measuring resting energy expenditure, its routine clinical use is constrained by practical challenges, including procedural complexity, time-intensive nature, significant cost, and limited feasibility in patients on advanced life support, such as extracorporeal membrane oxygenation (ECMO). Dysregulation of glucose metabolism is common in this population, characterized not only by absolute dysglycemia but also-and perhaps more critically-by impairments in the efficiency of glucose transport and utilization across the microcirculatory continuum (from arterial blood, through the interstitial space, to venous return). This study seeks to examine the relationship between novel dynamic metrics-such as the arterio-interstitial glucose gradient-and key clinical parameters, including energy expenditure, organ function, and patient outcomes. Our objective is to assess the utility of these measures as minimally invasive, real-time biomarkers of metabolic state in critical illness.

Read the detailed description

This prospective observational study aims to investigate the association between blood-interstitial fluid glucose concentration differences and resting energy expenditure, organ function, and clinical outcomes in critically ill patients, while also exploring potential factors influencing these glucose concentration differences.

Keywords
Glucose Gap, Metabolic Monitoring, Critically Ill Patients, Prognosis, Insulin Resistance
Medical subject headings
Critical Illness, Metabolic Diseases, Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICU Mortality

    The incidence of all-cause death during the patient's stay in the Intensive Care Unit

    Measured: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days

Secondary outcomes (3)

  1. Duration of Vasopressor Dependency

    The total length of time a patient requires continuous intravenous vasoactive drugs to maintain adequate blood pressure.

    Measured: From date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 days

  2. Duration of Invasive Mechanical Ventilation

    The total length of time a patient requires endotracheal intubation and support from a mechanical ventilator.

    Measured: From date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 days

  3. Duration of Continuous Renal Replacement Therapy (CRRT)

    The total length of time a patient requires continuous renal replacement therapy for acute kidney injury.

    Measured: From date of study enrollment until the date of CRRT discontinuation for at least 24 hours or death from any cause, whichever came first, assessed up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start13 Jul 2023
  3. Primary completion13 Mar 2024
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07240103
Sponsor's protocol ID
Glucose Gap
Status last verified
Oct 2025
First submitted
13 Nov 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Houben AJHM, Martens RJH, Stehouwer CDA. Assessing Microvascular Function in Humans from a Chronic Disease Perspective. J Am Soc Nephrol. 2017 Dec;28(12):3461-3472. doi: 10.1681/ASN.2017020157. Epub 2017 Sep 13.

    PubMed 28904002

  • Gouvea Bogossian E, Taleb C, Aspide R, Badenes R, Battaglini D, Bilotta F, Blandino Ortiz A, Caricato A, Castioni CA, Citerio G, Ferraro G, Martino C, Melchionda I, Montanaro F, Monleon Lopez B, Nato CG, Piagnerelli M, Picetti E, Robba C, Simonet O, Thooft A, Taccone FS. Cerebro-spinal fluid glucose and lactate concentrations changes in response to therapies in patIents with primary brain injury: the START-TRIP study. Crit Care. 2023 Mar 31;27(1):130. doi: 10.1186/s13054-023-04409-6.

    PubMed 37004053

  • Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.

    PubMed 34605781

  • Nuyttens L, Heyerick M, Heremans G, Moens E, Roes M, Van Dender C, De Bus L, Decruyenaere J, Dewaele J, Vandewalle J, Libert C. Unraveling mitochondrial pyruvate dysfunction to mitigate hyperlactatemia and lethality in sepsis. Cell Rep. 2025 Aug 26;44(8):116032. doi: 10.1016/j.celrep.2025.116032. Epub 2025 Jul 21.

    PubMed 40694477

  • Jaiswal N, Gavin MG, Quinn WJ 3rd, Luongo TS, Gelfer RG, Baur JA, Titchenell PM. The role of skeletal muscle Akt in the regulation of muscle mass and glucose homeostasis. Mol Metab. 2019 Oct;28:1-13. doi: 10.1016/j.molmet.2019.08.001. Epub 2019 Aug 5.

    PubMed 31444134

  • Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care Med. 2013 Jun;41(6):e93-4. doi: 10.1097/CCM.0b013e318283d124. No abstract available.

    PubMed 23685597

  • Mahdavi S, Anthony NM, Sikaneta T, Tam PY. Perspective: Multiomics and Artificial Intelligence for Personalized Nutritional Management of Diabetes in Patients Undergoing Peritoneal Dialysis. Adv Nutr. 2025 Mar;16(3):100378. doi: 10.1016/j.advnut.2025.100378. Epub 2025 Jan 20.

    PubMed 39842720

  • Achamrah N, Delsoglio M, De Waele E, Berger MM, Pichard C. Indirect calorimetry: The 6 main issues. Clin Nutr. 2021 Jan;40(1):4-14. doi: 10.1016/j.clnu.2020.06.024. Epub 2020 Jul 2.

    PubMed 32709554

  • De Waele E, van Zanten ARH. Routine use of indirect calorimetry in critically ill patients: pros and cons. Crit Care. 2022 May 5;26(1):123. doi: 10.1186/s13054-022-04000-5. No abstract available.

    PubMed 35513872

  • Moonen HPFX, Beckers KJH, van Zanten ARH. Energy expenditure and indirect calorimetry in critical illness and convalescence: current evidence and practical considerations. J Intensive Care. 2021 Jan 12;9(1):8. doi: 10.1186/s40560-021-00524-0.

    PubMed 33436084

  • Graf S, Karsegard VL, Viatte V, Heidegger CP, Fleury Y, Pichard C, Genton L. Evaluation of three indirect calorimetry devices in mechanically ventilated patients: which device compares best with the Deltatrac II((R))? A prospective observational study. Clin Nutr. 2015 Feb;34(1):60-5. doi: 10.1016/j.clnu.2014.01.008. Epub 2014 Jan 21.

    PubMed 24485773

  • Lakenman PLM, van der Hoven B, van Bommel J, Olieman JF, Joosten KFM. The usefulness of a new indirect calorimeter in critically ill adult patients. Clin Nutr. 2024 Oct;43(10):2267-2272. doi: 10.1016/j.clnu.2024.07.048. Epub 2024 Aug 7.

    PubMed 39208718

  • de Goes CR, Berbel-Bufarah MN, Sanches AC, Xavier PS, Balbi AL, Ponce D. Poor Agreement between Predictive Equations of Energy Expenditure and Measured Energy Expenditure in Critically Ill Acute Kidney Injury Patients. Ann Nutr Metab. 2016;68(4):276-84. doi: 10.1159/000446708. Epub 2016 Jun 10.

    PubMed 27288392

  • Harris JA, Benedict FG. A Biometric Study of Human Basal Metabolism. Proc Natl Acad Sci U S A. 1918 Dec;4(12):370-3. doi: 10.1073/pnas.4.12.370. No abstract available.

    PubMed 16576330

  • Zusman O, Theilla M, Cohen J, Kagan I, Bendavid I, Singer P. Resting energy expenditure, calorie and protein consumption in critically ill patients: a retrospective cohort study. Crit Care. 2016 Nov 10;20(1):367. doi: 10.1186/s13054-016-1538-4.

    PubMed 27832823

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Metabolism Disorders, run by Chinese Medical Association at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICU Mortality (time frame: From date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07240103, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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