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NCT Number: NCT07499401

Evaluation of the Microcirculatory Response to Fluids in Critically Ill Patients With Venous Congestion: A Prospective Observational Study

The hypothesis is that fluid-responsive patients who show signs of venous congestion experience a worsening of microcirculatory status after fluid administration compared to patients without signs of venous congestion

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Key information

Conditions

Venous Congestion Cardiovascular Diseases Hyperemia Microcirculation Vascular Diseases Volume Expansion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Critically ill patients admitted to the intensive care unit
  • Invasive or minimally invasive hemodynamic monitoring

Exclusion criteria

  • Suspected or confirmed pregnancy
  • Inability to access the oral cavity (e.g., facial trauma, oral bleeding)

Treatment and study plan

fluid challenge

Drug

Signs of venous congestion and microcirculatory status will be assessed at baseline. A fluid challenge will then be performed, and microcirculation will be evaluated at the end of fluid administration and again after 30 minutes

Primary outcomes

  1. Change in Sublingual total vessel density (TVD)

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual microcirculatory parameter - total vessel density (TVD) - before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in preload-dependent patients with and without signs of venous congestion.

Secondary outcomes

  1. Change in Sublingual percentage of perfused vessels (PPV)

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual microcirculatory parameter - percentage of perfused vessels (PPV) - before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in preload-dependent patients with and without signs of venous congestion.

  2. Change in Sublingual Microcirculatory Flow Index (MFI)

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    The primary objective of the study is to compare changes in sublingual microcirculation, measured by the Microcirculatory Flow Index (MFI), before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in preload-dependent patients with and without signs of venous congestion.

  3. Change in Sublingual perfused vessel density (PVD)

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual microcirculatory parameters - perfused vessel density (PVD) - before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in preload-dependent patients with and without signs of venous congestion.

  4. Change in Sublingual microcirculatory heterogeneity index (MHI)

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual microcirculatory parameters - microcirculatory heterogeneity index (MHI) - before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in preload-dependent patients with and without signs of venous congestion.

  5. Change in Sublingual PPV in Non-Preload-Dependent Patients With and Without Venous Congestion

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual PPV before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in non-preload-dependent patients with and without signs of venous congestion.

  6. Change in Sublingual TVD in Non-Preload-Dependent Patients With and Without Venous Congestion

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual TVD before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in non-preload-dependent patients with and without signs of venous congestion.

  7. Change in Sublingual MFI in Non-Preload-Dependent Patients With and Without Venous Congestion

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual MFI before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in non-preload-dependent patients with and without signs of venous congestion.

  8. Change in Sublingual PVD in Non-Preload-Dependent Patients With and Without Venous Congestion

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual PVD before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in non-preload-dependent patients with and without signs of venous congestion.

  9. Change in Sublingual MHI in Non-Preload-Dependent Patients With and Without Venous Congestion

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To compare changes in sublingual MHI before fluid administration, immediately after volume expansion, and 30 minutes post-fluid administration in non-preload-dependent patients with and without signs of venous congestion.

  10. Association Between Venous Congestion and TVD in Critically Ill Patients and Subpopulations

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    o evaluate the relationship between signs of venous congestion TVD at baseline, after fluid administration, and 30 minutes post-fluid administration in critically ill patients and subgroups (e.g., septic shock).

  11. Association Between Venous Congestion and PVD in Critically Ill Patients and Subpopulations

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To evaluate the relationship between signs of venous congestion and PVD at baseline, after fluid administration, and 30 minutes post-fluid administration in critically ill patients and subgroups (e.g., septic shock).

  12. Association Between Venous Congestion and MFI in Critically Ill Patients and Subpopulations

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To evaluate the relationship between signs of venous congestion and MFI at baseline, after fluid administration, and 30 minutes post-fluid administration in critically ill patients and subgroups (e.g., septic shock).

  13. Association Between Venous Congestion and PPV in Critically Ill Patients and Subpopulations

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To evaluate the relationship between signs of venous congestion and PPV at baseline, after fluid administration, and 30 minutes post-fluid administration in critically ill patients and subgroups (e.g., septic shock).

  14. Association Between Venous Congestion and MHI in Critically Ill Patients and Subpopulations

    Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

    To evaluate the relationship between signs of venous congestion and MHI at baseline, after fluid administration, and 30 minutes post-fluid administration in critically ill patients and subgroups (e.g., septic shock).

  15. Association Between Venous Congestion and TVD at Baseline

    Time frame: Baseline

    To evaluate the association between signs of venous congestion and TVD at baseline in critically ill patients and subgroups (e.g., septic shock).

  16. Association Between Venous Congestion and PVD at Baseline

    Time frame: Baseline

    To evaluate the association between signs of venous congestion and PVD at baseline in critically ill patients and subgroups (e.g., septic shock).

  17. Association Between Venous Congestion and MFI at Baseline

    Time frame: Baseline

    To evaluate the association between signs of venous congestion and MFI at baseline in critically ill patients and subgroups (e.g., septic shock).

  18. Association Between Venous Congestion and PPV at Baseline

    Time frame: Baseline

    To evaluate the association between signs of venous congestion and PPV at baseline in critically ill patients and subgroups (e.g., septic shock).

  19. Association Between Venous Congestion and MHI at Baseline

    Time frame: Baseline

    To evaluate the association between signs of venous congestion and MHI at baseline in critically ill patients and subgroups (e.g., septic shock).

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Acronym: MICRO-CONGEST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Apr 2, 2026

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

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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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