ARDSVISC-ARDSNCT07823296
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
An observational study of ARDS, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- Blood draws (peripheral venous puncture) and Blood draws (arterial catheter, central venous line, or Swan-Ganz catheter)
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients treated at the Croix Rousse Hospital
Who may be able to join
- 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)
- Age ≥ 18 ans
- Participation agreement obtained (either from the patient themselves or from a relative)
Who cannot join
- 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
Show all 17Show fewer
- Hemoglobin < 70 g/dL
- Control group
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital de la Croix-Rousse
Lyon, 69004
Hippolyte LEQUAIN, Dr, 0472071281 ext. +33, hippolyte.lequain@chu-lyon.fr
Loredana BABOI, 0472009265 ext. +33, Loredana.baboi@chu-lyon.fr
About this study
Official title: Assessment of Blood Viscosity in ARDS
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.
Read more
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
- Being tested
- Blood draws (peripheral venous puncture), Blood draws (arterial catheter, central venous line, or Swan-Ganz catheter)
- Keywords
- ards, blood viscosity, prospective case-control study
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients over 18 years of age with moderate to severe ARDS (overall definition) (P/F <200) Receives: 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 Receives: Biological: Blood draws (peripheral venous puncture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start27 Oct 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823296
- Sponsor's protocol ID
- 69HCL26_0689
- Other IDs
- ID-RCB
- Acronym
- VISC-ARDS
- Status last verified
- Nov 2026
- First submitted
- 11 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood Viscosity in ARDS
- ClinicalTrials.gov ID
- NCT07823296
- Acronym / sponsor ID
- VISC-ARDS / 69HCL26_0689
- Conditions
- ARDS
- Keywords
- ards, blood viscosity, prospective case-control study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Biological: Blood draws (peripheral venous puncture), Other: Blood draws (arterial catheter, central venous line, or Swan-Ganz catheter)Patients over 18 years of age with moderate to severe ARDS (overall definition) (P/F <200) |
| Control group | – | Biological: Blood draws (peripheral venous puncture)Patients admitted to intensive care unit without ARDS or sepsis/septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients treated at the Croix Rousse Hospital
Key inclusion criteria (6 listed)
- 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)
- Age ≥ 18 ans
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood 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. | Biological | Case group, Control group |
| Blood 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. | Other | Case group |
Primary outcome
Comparison of Blood Viscosity in Patients with ARDS and Control Group on Day 1
Time frame: At 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hippolyte LEQUAIN, Dr (0472071281 ext. +33, hippolyte.lequain@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Blood Viscosity in Patients with ARDS and Control Group on Day 1 (time frame: At day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.