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

NCT07499401 | Recruiting

• 1 other identifier: Prot. 2024 213
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Congestion; Microcirculation; Volume Expansion

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

Secondary Outcomes (19)

• Change in Sublingual percentage of perfused vessels (PPV)

  Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

• Change in Sublingual Microcirculatory Flow Index (MFI)

  Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

• Change in Sublingual perfused vessel density (PVD)

  Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

• Change in Sublingual microcirculatory heterogeneity index (MHI)

  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

  Baseline, immediately post-fluid challenge, and 30 minutes post-fluid challenge

Interventions

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

Eligibility Criteria

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

Study Population

Critically ill patients admitted to the intensive care unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

AOU delle Marche

Ancona, Italy, 60123, Italy

RECRUITING

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Full Professor of Intensive Care, Head of the ICU

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: March 30, 2026
• Study Start: December 15, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

IT (1)