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RecruitingNCT07823296VISC-ARDSUpdated Nov 6, 2026

Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)

An observational study in ARDS, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Hospices Civils de Lyon · Observational

Updated Nov 6, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
46
Ages
18 Years and older
Sex
All
01

Study summary

Acute respiratory distress syndrome (ARDS) is characterized by damage to the alveolar-capillary membrane, resulting in hypoxemia, decreased pulmonary compliance, and hemodynamic changes.

Critical conditions (hypoxia; septic shock associated with ARDS) can alter blood viscosity. These changes in viscosity can affect blood flow and hemodynamics.

There is only one clinical study that has measured one of the determinants of blood viscosity in ARDS (deformability), even though other parameters are involved in viscosity (elongation, deformability, hematocrit, etc.), and it is possible to measure blood viscosity comprehensively. To date, therefore, no study has evaluated the various parameters of blood viscosity in ARDS.

The aim of this study is to investigate hyperviscosity in patients with ARDS and to assess whether this hyperviscosity correlates with respiratory or hemodynamic changes.

The investigators will therefore compare blood viscosity and its determinants in patients admitted to the intensive care unit for ARDS and in patients admitted for other reasons (excluding ARDS or sepsis/septic shock).

The investigators will also conduct a longitudinal assessment of changes in hemodynamic, respiratory, and viscosity parameters during ARDS

02

Conditions studied

  • ARDS

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Keywords

  • ards
  • blood viscosity
  • prospective case-control study
03

In context

Acute Lung Injury

382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.

This study's planned enrollment of 46 is below the median of 100 across 131 observational studies indexed under Acute Lung Injury.

Browse Acute Lung Injury studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Intensive care patients treated at the Croix Rousse Hospital

Eligibility criteria

Case Group

Inclusion Criteria:

  • Age ≥ 18 ans
  • Moderate-to-severe ARDS according to the global definition:
  • with PaO₂/FiO₂ ≤ 200 mmHg (based on arterial blood gas analysis in patients receiving invasive or non-invasive mechanical ventilation or high-flow nasal oxygen therapy).
  • Participation agreement obtained (either from the patient themselves or from a relative)

Exclusion Criteria:

  • ARDS that has been present for more than 72 hours
  • Terminally ill patient with death expected within 24 hours
  • Patient who has received a blood transfusion within the past month
  • Patient with a known hematologic (lymphoma; myeloma; acute or chronic leukemia)
  • Patient with a known hemoglobinopathy.
  • Hemorrhagic shock
  • \< 70 g/dL

Control group

Inclusion Criteria:

  • Age ≥ 18 ans
  • Participation agreement obtained (either from the patient themselves or from a relative)

Exclusion Criteria:

  • Presence of ARDS according to the global definition
  • P/F \< 300 mmHg
  • Presence of sepsis defined by an infection and a SOFA score delta ≥ 2.
  • Terminally ill patient with death expected within 24 hours
  • Patient who has received a blood transfusion within the past month
  • Patient with a known hematologic malignancy (lymphoma; myeloma; acute or chronic leukemia)
  • Patient with a known hemoglobinopathy.
  • Hemorrhagic shock
  • Hemoglobin \< 70 g/dL
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
46 participants (estimated)
Patient registry
No

Groups and cohorts

  • Case group

    Patients over 18 years of age with moderate to severe ARDS (overall definition) (P/F \<200)

    Biological: Blood draws (peripheral venous puncture) · Other: Blood draws (arterial catheter, central venous line, or Swan-Ganz catheter)

  • Control group

    Patients admitted to intensive care unit without ARDS or sepsis/septic shock

    Biological: Blood draws (peripheral venous puncture)

Interventions

  • BiologicalBlood draws (peripheral venous puncture)

    Procedure performed by intensive care nurses. Case group : Daily blood draws (4 mL) for 7 days. Control group : blood draws (4 mL) on Day 1.

  • OtherBlood draws (arterial catheter, central venous line, or Swan-Ganz catheter)

    Case group : For patients with an arterial catheter, central venous line, or Swan-Ganz catheter, an additional blood sample will be collected on Day 1.

06

What researchers measure

Primary outcomes

  1. Comparison of Blood Viscosity in Patients with ARDS and Control Group on Day 1

    Blood viscosity will be determined after complete oxygenation of the blood, at native hematocrit, at a temperature of 25 °C. Measurements will be performed at different shear rates (11.5, 22.5, 45, 90, and 225 s-¹) using a cone-plate viscometer (Brookfield DVII+ equipped with a CPE40 cone, Brookfield Engineering Labs, Natick, MA, USA). This technique is based on applying a well-defined shear rate gradient between a moving conical surface and a fixed flat surface, with the blood sample placed between them. The fluid subjected to this shear resists flow in proportion to its viscosity. The higher the viscosity, the greater the torque required to maintain motion. This approach allows for the precise measurement of the apparent viscosity of blood across a wide range of mechanical stresses, replicating the flow conditions encountered in the bloodstream. The value at 225 s-¹ will be used as the primary endpoint (with an accuracy of 5-10 centipoise at this shear rate).

    Time frame: At day 1

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 6, 2026
Sites
Hopital de la Croix-Rousse is now Recruiting
Nov 6, 2026
Start date
Oct 1, 2026→Oct 27, 2026 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Not yet recruiting→Recruiting
    Hopital de la Croix-Rousse is now Recruiting
    Start date Oct 1, 2026→Oct 27, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07823296
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Oct 27, 2026
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Hippolyte LEQUAIN, Dr
Contact
hippolyte.lequain@chu-lyon.fr
0472071281 ext. +33
Jean-Christophe RICHARD, Pr
Contact
j-christophe.richard@chu-lyon.fr
0472009272 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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