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NCT Number: NCT07240103

Blood-Interstitial Fluid Glucose Gap

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Duration of Vasopressor Dependency

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

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

  2. Duration of Invasive Mechanical Ventilation

    Time frame: 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

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

  3. Duration of Continuous Renal Replacement Therapy (CRRT)

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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