Acute Respiratory Distress Syndrome (ARDS)Phase 4IROCANCT01763853
Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)
A Phase 4 study testing 4% albumin in people with Acute Respiratory Distress Syndrome (ARDS) and Hypovolemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Hypovolemia, Pulmonary Edema
- What is being tested?
- 4% albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of moderate or severe ARDS, as defined by the Berlin definition (JAMA. 2012;307(23):2526-2533)
- Hypovolemia requiring fluid resuscitation therapy
Who cannot join
- Pregnancy
- Age under 18
- Refusal of the protocol
- Contraindications for the use of Voluven© or Ringer Lactate©
- Contraindications for femoral artery catheterization or subclavian venous catheterization
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick Lacarin, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Fluid challenge may have adverse side effects associated with fluid administration. The diffusion within the interstitial space may favor edema formation and cause cardiac dysfunction by volume overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial integrity, leading to enhanced alveolar edema and impaired gas exchange.
Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids and compared to crystalloids, albumin has the theoretical advantage of causing greater volume expansion.
Read more
We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary edema than a fluid resuscitation therapy with crystalloids.
The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema fluid resorption, in 2 groups of patients: those treated with albumin and those treated with crystalloid.
Read the detailed description
The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
The evolution of respiratory and hemodynamic parameters, as measured by transpulmonary thermodilution (extra-vascular lung water, pulmonary vascular permeability index, cardiac output, global enddiastolic volume), plasma osmolality, plasma oncotic pressure and plasma levels of brain natriuretic peptid (BNP) will be studied one hour and 3 hours after after fluid resuscitation in the two groups. In order to evaluate alveolar epithelial dysfunction in patients receiving either albumin or crystalloid, plasma and alveolar levels of sRAGE (the soluble form of the receptor for advanced glycation endproducts) will be measured by ELISA. Lung aeration and fluid-induced derecruitment will be evaluated with an electrical impedance tomograph (PulmoVista®500, Dräger).
- Being tested
- 4% albumin
- Keywords
- Acute respiratory distress syndrome (ARDS), Pulmonary edema, Alveolar fluid clearance, Alveolar epithelial dysfunction, Receptor for advanced glycation end-products (RAGE), Fluid resuscitation therapy, Hypovolemia, Crystalloid, Hydroxyethyl Starch, Intensive care unit
- Medical subject headings
- Respiratory Distress Syndrome, Hypovolemia, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% albuminDrug
| Study group | Role | What they receive |
|---|---|---|
| albumin | Other | The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists). Receives: Drug: 4% albumin |
| crystalloid | Other | The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists). Receives: Drug: 4% albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of alveolar fluid clearance
Measured: one hour after administration of fluid resuscitation
Secondary outcomes (20)
Extra-vascular lung water
Measured: one hour and three hours after administration of fluid resuscitation
Pulmonary vascular permeability index
Measured: one hour and three hours after administration of fluid resuscitation
Global enddiastolic volume index
Measured: one hour and three hours after administration of fluid resuscitation
mean arterial pressure
Measured: one hour and three hours after administration of fluid resuscitation
cardiac output
Measured: one hour and three hours after administration of fluid resuscitation
pulse pressure variation
Measured: one hour and three hours after administration of fluid resuscitation
stroke volume variation
Measured: one hour and three hours after administration of fluid resuscitation
central venous venous oxygenation
Measured: one hour and three hours after administration of fluid resuscitation
central venous pressure
Measured: one hour and three hours after administration of fluid resuscitation
PaO2
Measured: one hour and three hours after administration of fluid resuscitation
lung compliance
Measured: one hour and three hours after administration of fluid resuscitation
airways resistance
Measured: one hour and three hours after administration of fluid resuscitation
lung injury score
Measured: one hour and three hours after administration of fluid resuscitation
Plasma levels of sRAGE
Measured: one hour and three hours after administration of fluid resuscitation
Alveolar levels of sRAGE
Measured: one hour and three hours after administration of fluid resuscitation
Brain natriuretic peptide levels
Measured: one hour and three hours after administration of fluid resuscitation
Plasma osmolarity
Measured: one hour and three hours after administration of fluid resuscitation
Oncotic pressure
Measured: one hour and three hours after administration of fluid resuscitation
Electrical impedance tomography
Measured: one hour and three hours after administration of fluid resuscitation
Mortality
Measured: Day 20, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- R2D2 Retinoids, Reproduction Developmental Diseases, Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Matthieu JABAUDON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763853
- Sponsor's protocol ID
- CHU-0134
- Acronym
- IROCA
- Status last verified
- Jul 2016
- First submitted
- 10 Dec 2012
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT01763853
- Acronym / sponsor ID
- IROCA / CHU-0134
- Keywords
- Acute respiratory distress syndrome (ARDS), Pulmonary edema, Alveolar fluid clearance, Alveolar epithelial dysfunction, Receptor for advanced glycation end-products (RAGE), Fluid resuscitation therapy, Hypovolemia, Crystalloid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- R2D2 Retinoids, Reproduction Developmental Diseases, Université d'Auvergne
- Study start
- Dec 2012
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 9 Jan 2013 (estimated)
- 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.
The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Fluid challenge may have adverse side effects associated with fluid administration. The diffusion within the interstitial space may favor edema formation and cause cardiac dysfunction by volume overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial integrity, leading to enhanced alveolar edema and impaired gas exchange.
Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids and compared to crystalloids, albumin has the theoretical advantage of causing greater volume expansion.
We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary edema than a fluid resuscitation therapy with crystalloids.
The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema fluid resorption, in 2 groups of patients: those treated with albumin and those treated with crystalloid.
Detailed description
The main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists).
The evolution of respiratory and hemodynamic parameters, as measured by transpulmonary thermodilution (extra-vascular lung water, pulmonary vascular permeability index, cardiac output, global enddiastolic volume), plasma osmolality, plasma oncotic pressure and plasma levels of brain natriuretic peptid (BNP) will be studied one hour and 3 hours after after fluid resuscitation in the two groups. In order to evaluate alveolar epithelial dysfunction in patients receiving either albumin or crystalloid, plasma and alveolar levels of sRAGE (the soluble form of the receptor for advanced glycation endproducts) will be measured by ELISA. Lung aeration and fluid-induced derecruitment will be evaluated with an electrical impedance tomograph (PulmoVista®500, Dräger).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| albumin | Other | Drug: 4% albuminThe main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists). |
| crystalloid | Other | Drug: 4% albuminThe main objective of our prospective double blind, randomized, controlled trial is to compare the rate of alveolar fluid clearance, a marker of alveolar edema fluid resorption, in 2 groups of patients with ARDS and suffering from hypovolemia: those treated with albumin and those treated with crystalloid (fluid challenge of 7 mL/kg over 15 minutes, that can be repeated 3 times if hypovolemia persists). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICU patients under mechanical ventilation
- Patients within the first 24 hours after onset of moderate or severe ARDS, as defined by the Berlin definition (JAMA. 2012;307(23):2526-2533)
- Hypovolemia requiring fluid resuscitation therapy
Key exclusion criteria (5 listed)
- Pregnancy
- Age under 18
- Refusal of the protocol
- Contraindications for the use of Voluven© or Ringer Lactate©
- Contraindications for femoral artery catheterization or subclavian venous catheterization
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 |
|---|---|---|
| 4% albumin | Drug | albumin, crystalloid |
Primary outcome
Rate of alveolar fluid clearance
Time frame: one hour after administration of fluid resuscitation
20 secondary outcomes
Extra-vascular lung water
Time frame: one hour and three hours after administration of fluid resuscitation
Pulmonary vascular permeability index
Time frame: one hour and three hours after administration of fluid resuscitation
Global enddiastolic volume index
Time frame: one hour and three hours after administration of fluid resuscitation
mean arterial pressure
Time frame: one hour and three hours after administration of fluid resuscitation
cardiac output
Time frame: one hour and three hours after administration of fluid resuscitation
pulse pressure variation
Time frame: one hour and three hours after administration of fluid resuscitation
stroke volume variation
Time frame: one hour and three hours after administration of fluid resuscitation
central venous venous oxygenation
Time frame: one hour and three hours after administration of fluid resuscitation
central venous pressure
Time frame: one hour and three hours after administration of fluid resuscitation
PaO2
Time frame: one hour and three hours after administration of fluid resuscitation
lung compliance
Time frame: one hour and three hours after administration of fluid resuscitation
airways resistance
Time frame: one hour and three hours after administration of fluid resuscitation
lung injury score
Time frame: one hour and three hours after administration of fluid resuscitation
Plasma levels of sRAGE
Time frame: one hour and three hours after administration of fluid resuscitation
Alveolar levels of sRAGE
Time frame: one hour and three hours after administration of fluid resuscitation
Brain natriuretic peptide levels
Time frame: one hour and three hours after administration of fluid resuscitation
Plasma osmolarity
Time frame: one hour and three hours after administration of fluid resuscitation
Oncotic pressure
Time frame: one hour and three hours after administration of fluid resuscitation
Electrical impedance tomography
Time frame: one hour and three hours after administration of fluid resuscitation
Mortality
Time frame: Day 20, Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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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. This study is not recruiting at the moment.
Matthieu JABAUDON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 4% albumin in people with Acute Respiratory Distress Syndrome (ARDS) and Hypovolemia, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jul 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of alveolar fluid clearance (time frame: one hour after administration of fluid resuscitation). 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 29 Jul 2016.