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

NCT07823296 | Not Yet Recruiting

• 2 other identifiers: 69HCL26_0689ID-RCB
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ARDS

Keywords

ards; blood viscosity; prospective case-control study

Outcome Measures

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).

  At day 1

Study Arms (2)

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

Blood draws (peripheral venous puncture) BIOLOGICAL

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.

Case group; Control group

Blood draws (arterial catheter, central venous line, or Swan-Ganz catheter) OTHER

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.

Case group

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

Intensive care patients treated at the Croix Rousse Hospital

You may qualify if:

• 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)

You may not qualify if:

• 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 malignancy (lymphoma; myeloma; acute or chronic leukemia)
• Patient with a known hemoglobinopathy.
• Hemorrhagic shock
• Hemoglobin \< 70 g/dL
• Control group
• Age ≥ 18 ans
• Participation agreement obtained (either from the patient themselves or from a relative)
• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital de la Croix-Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Blood Specimen Collection; Central Venous Catheters

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Vascular Access Devices; Catheters; Equipment and Supplies

Central Study Contacts

Hippolyte LEQUAIN, Dr

CONTACT

0472071281; hippolyte.lequain@chu-lyon.fr

Jean-Christophe RICHARD, Pr

CONTACT

0472009272; j-christophe.richard@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

FR (1)