The Blood-Interstitial Glucose Gap

NCT07251764 | Completed DMC

• 1 other identifier: Zhibo Zhang
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Metabolism Disorders

Keywords

Glucose Gap; Metabolic Monitoring; Prognosis; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

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

  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)

• Duration of Vasopressor Dependency

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

• Duration of Invasive Mechanical Ventilation

  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

• 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 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill patient

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Critical Illness; Metabolic Diseases; Insulin Resistance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Wenkui Yu, Professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: July 13, 2023
• Primary Completion: March 13, 2024
• Study Completion: October 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CN (1)