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Recruiting NCT07499401

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

— Observational Venous Congestion Microcirculation Volume Expansion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fluid challenge.
Who it may be relevant to
Registry conditions: Venous Congestion, Microcirculation, Volume Expansion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug fluid challenge
    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 outcome measures

  • Change in Sublingual total vessel density (TVD) [Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge]
Secondary outcome measures (12)
  • Change in Sublingual percentage of perfused vessels (PPV) [Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge]
  • Change in Sublingual Microcirculatory Flow Index (MFI) [Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge]
  • Change in Sublingual perfused vessel density (PVD) [Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge]
  • Change in Sublingual microcirculatory heterogeneity index (MHI) [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 [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 [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 [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 [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 [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 [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 [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 [Time frame: Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • AOU delle Marche — Ancona

Identifiers

NCT: NCT07499401 · Prot. 2024 213

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗