Skip to content

Blood-Interstitial Fluid Glucose Gap

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07240103
Enrollment
140
Registered
2025-11-20
Start date
2023-07-13
Completion date
2025-10-01
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Metabolism Disorders

Keywords

Glucose Gap, Metabolic Monitoring, Critically Ill Patients, Prognosis, Insulin Resistance

Brief 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 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.

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.

Interventions

None listed

Sponsors

Chinese Medical Association
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
ICU MortalityFrom date of study enrollment until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 60 daysThe incidence of all-cause death during the patient's stay in the Intensive Care Unit

Secondary

MeasureTime frameDescription
Duration of Vasopressor DependencyFrom date of study enrollment until the date of vasopressor cessation for at least 24 hours, assessed up to 30 daysThe total length of time a patient requires continuous intravenous vasoactive drugs to maintain adequate blood pressure.
Duration of Invasive Mechanical VentilationFrom date of study enrollment until the date of successful extubation, tracheostomy, or death from any cause, whichever came first, assessed up to 30 daysThe total length of time a patient requires endotracheal intubation and support from a mechanical ventilator.
Duration of Continuous Renal Replacement Therapy (CRRT)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 daysThe total length of time a patient requires continuous renal replacement therapy for acute kidney injury.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026