An observational study in Venous Congestion, Microcirculation and Volume Expansion, sponsored by Università Politecnica delle Marche. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Università Politecnica delle Marche · Observational
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
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 46 observational studies indexed under Hyperemia.
Browse Hyperemia studies →Università Politecnica delle Marche is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill patients admitted to the intensive care unit
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Exclusion Criteria:
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
Change in Sublingual total vessel density (TVD)
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual percentage of perfused vessels (PPV)
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual Microcirculatory Flow Index (MFI)
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual perfused vessel density (PVD)
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual microcirculatory heterogeneity index (MHI)
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual PPV in Non-Preload-Dependent Patients With and Without Venous Congestion
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual TVD in Non-Preload-Dependent Patients With and Without Venous Congestion
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual MFI in Non-Preload-Dependent Patients With and Without Venous Congestion
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual PVD in Non-Preload-Dependent Patients With and Without Venous Congestion
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Change in Sublingual MHI in Non-Preload-Dependent Patients With and Without Venous Congestion
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.
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Association Between Venous Congestion and TVD in Critically Ill Patients and Subpopulations
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).
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Association Between Venous Congestion and PVD in Critically Ill Patients and Subpopulations
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).
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Association Between Venous Congestion and MFI in Critically Ill Patients and Subpopulations
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).
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Association Between Venous Congestion and PPV in Critically Ill Patients and Subpopulations
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).
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Association Between Venous Congestion and MHI in Critically Ill Patients and Subpopulations
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).
Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge
Association Between Venous Congestion and TVD at Baseline
To evaluate the association between signs of venous congestion and TVD at baseline in critically ill patients and subgroups (e.g., septic shock).
Time frame: Baseline
Association Between Venous Congestion and PVD at Baseline
To evaluate the association between signs of venous congestion and PVD at baseline in critically ill patients and subgroups (e.g., septic shock).
Time frame: Baseline
Association Between Venous Congestion and MFI at Baseline
To evaluate the association between signs of venous congestion and MFI at baseline in critically ill patients and subgroups (e.g., septic shock).
Time frame: Baseline
Association Between Venous Congestion and PPV at Baseline
To evaluate the association between signs of venous congestion and PPV at baseline in critically ill patients and subgroups (e.g., septic shock).
Time frame: Baseline
Association Between Venous Congestion and MHI at Baseline
To evaluate the association between signs of venous congestion and MHI at baseline in critically ill patients and subgroups (e.g., septic shock).
Time frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jun 2026, 18 months after the start.
Of 28 observational studies under Hyperemia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 27. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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Università Politecnica delle Marche