Interstitial LiquidINTERSEPNCT05039151
Interstitial Fluid Composition in Patients With Septic Versus Non-septic Shock: an Exploratory Pilot Study
An observational study of Interstitial Liquid and Septic Shock, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Septic shock is a common reason for admission to intensive care units and severe infections are responsible for 6 million deaths a year worldwide. Fluid management appears to be a major issue in resuscitation and particularly in septic shock, where generalised oedema is almost systematic and is a major factor in poor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Liquid, Septic Shock
- What is being tested?
- interstitial fluid sampling and blood sampling
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 19 Jul 2025
- Phase
- Observational
- 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
Study population: ligible patients will be identified among patients admitted to Intensive Care Medicine
Who may be able to join
- COMMON INCLUSION CRITERIA
- Patient under mechanical ventilation and sedation
- Patient and/or trusted person (health care proxy) or close relative who has given their oral consent after being informed,
- Age ≥ 18 years old,
- Diagnosis within 24 hours of admission of septic shock as defined by :
- A probable or confirmed infection
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- And a SOFA score ≥ 2
- And the need to introduce vasopressors to obtain a MAP ≥ 65 mmHg despite adequate vascular filling
- And an arterial lactate > 2 mmol/l
- Norepinephrine dose greater than 0.1 μg/kg/min
- Septic shock present for less than 48 hours
- Absence of sepsis and shock from any cause within 2 months prior to inclusion
Who cannot join
- Disseminated intravascular coagulation (DIC) with haemorrhagic syndrome
- Acute condition that can mimic sepsis :
- Acute pancreatitis without signs of superinfection
- Metformin Intoxication
- Patient with an unfavourable prognosis within 24 hours
- Patient under legal protection (safeguard of justice, guardianship or tutelage)
- Pregnant or breastfeeding women
- Patient not affiliated to national health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Septic shock is a common reason for admission to intensive care units and severe infections are responsible for 6 million deaths a year worldwide. Fluid management appears to be a major issue in resuscitation and particularly in septic shock, where generalised oedema is almost systematic and is a major factor in poor prognosis during sepsis. The formation of oedema corresponds to an imbalance, according to Frank-Starling's law of the heart, between the vascular compartment and the interstitial compartment, which is composed of the interstitial liquid and an extracellular matrix. This extracellular matrix consists essentially of a network of collagen and fibroblast fibres. Even though all of the plasma in the body transits through the interstitium in 24 hours and desite its major importance in the microenvironment and intercellular communication, the interstitial compartment has not been fully described. In oncology, interstitial tissue seems to contribute to tumour growth through changes in matrix composition and pressure in the interstitium. This pressure actively contributes to the regulation of transcapillary filtration, and thus to the oedema and hypovolemia observed during sepsis. In usual conditions, the fibroblasts exert a tension on the collagen fibres of the matrix via integrin Beta-1 (ITGB1). This tension is released under the action of pro-inflammatory mediators, resulting in negative pressure which potentiates the formation of oedema.
It has been shown in an endotoxemia model that there is a thousandfold higher concentration of ITGB1 in the interstitium compared to the vascular compartment, suggesting a local secretion of this cytokine. The alteration of the extracellular matrix could also play a role in the perpetuation of oedema during septic shock. Considered as an organ in its own right, interstitial tissue is far from playing a passive role between the vascular compartment and the cells. The hypothesis is that interstitial fluid analysis could improve our understanding of the physiopathology of sepsis, in particular on the alteration of the mechanisms of fluid movement regulation, which remains very poorly understood while being closely associated with prognosis in patients with sepsis.
- Conditions
- Interstitial Liquid, Septic Shock
- Being tested
- interstitial fluid sampling, blood sampling
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interstitial fluid samplingBiological
The sample will be taken via three small catheters (thinner than the catheters used for conventional infusions) under the skin in the abdomen. 1 to 10 ml of interstitial liquid will be collected. A sample will be taken on D1 and D2.
blood samplingBiological
A blood sample (3 x 5 ml EDTA tubes) will be taken simultaneously. A sample will be taken on D1 and D2
| Study group | Role | What they receive |
|---|---|---|
| septic shock | 50 patients with a diagnosis of septic shock established within 24 hours of admission with oedemas Receives: Biological: interstitial fluid sampling; Biological: blood sampling | |
| control | 35 non-septic patients with oedema from another cause Receives: Biological: interstitial fluid sampling; Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of the differents components of the extracellular matrix on interstitial liquid at Day 1
Composition of the extracellular matrix on interstitial liquid on Day 1 (day of the first sampling) for the :
- Type(s) of collagen by ELISA technique on 5L of liquid
- Identification and quantification of interstitial glycosaminoglycans
Measured: on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start25 Jan 2021
- Primary completion19 Jul 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial LiquidStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039151
- Sponsor's protocol ID
- LABRUYERE CRBFC-A 2020
- Acronym
- INTERSEP
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Fluid Composition in Patients With Septic Versus Non-septic Shock: an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT05039151
- Acronym / sponsor ID
- INTERSEP / LABRUYERE CRBFC-A 2020
- Conditions
- Interstitial Liquid, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 19 Jul 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 9 Sep 2021 (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.
Septic shock is a common reason for admission to intensive care units and severe infections are responsible for 6 million deaths a year worldwide. Fluid management appears to be a major issue in resuscitation and particularly in septic shock, where generalised oedema is almost systematic and is a major factor in poor prognosis during sepsis. The formation of oedema corresponds to an imbalance, according to Frank-Starling's law of the heart, between the vascular compartment and the interstitial compartment, which is composed of the interstitial liquid and an extracellular matrix. This extracellular matrix consists essentially of a network of collagen and fibroblast fibres. Even though all of the plasma in the body transits through the interstitium in 24 hours and desite its major importance in the microenvironment and intercellular communication, the interstitial compartment has not been fully described. In oncology, interstitial tissue seems to contribute to tumour growth through changes in matrix composition and pressure in the interstitium. This pressure actively contributes to the regulation of transcapillary filtration, and thus to the oedema and hypovolemia observed during sepsis. In usual conditions, the fibroblasts exert a tension on the collagen fibres of the matrix via integrin Beta-1 (ITGB1). This tension is released under the action of pro-inflammatory mediators, resulting in negative pressure which potentiates the formation of oedema.
It has been shown in an endotoxemia model that there is a thousandfold higher concentration of ITGB1 in the interstitium compared to the vascular compartment, suggesting a local secretion of this cytokine. The alteration of the extracellular matrix could also play a role in the perpetuation of oedema during septic shock. Considered as an organ in its own right, interstitial tissue is far from playing a passive role between the vascular compartment and the cells. The hypothesis is that interstitial fluid analysis could improve our understanding of the physiopathology of sepsis, in particular on the alteration of the mechanisms of fluid movement regulation, which remains very poorly understood while being closely associated with prognosis in patients with sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| septic shock | – | Biological: interstitial fluid sampling, Biological: blood sampling50 patients with a diagnosis of septic shock established within 24 hours of admission with oedemas |
| control | – | Biological: interstitial fluid sampling, Biological: blood sampling35 non-septic patients with oedema from another cause |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ligible patients will be identified among patients admitted to Intensive Care Medicine
Key inclusion criteria (12 listed)
- COMMON INCLUSION CRITERIA
- Patient under mechanical ventilation and sedation
- Patient and/or trusted person (health care proxy) or close relative who has given their oral consent after being informed,
- Age ≥ 18 years old,
- Diagnosis within 24 hours of admission of septic shock as defined by :
Key exclusion criteria (8 listed)
- Disseminated intravascular coagulation (DIC) with haemorrhagic syndrome
- Acute condition that can mimic sepsis :
- Acute pancreatitis without signs of superinfection
- Metformin Intoxication
- Patient with an unfavourable prognosis within 24 hours
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 |
|---|---|---|
| interstitial fluid samplingThe sample will be taken via three small catheters (thinner than the catheters used for conventional infusions) under the skin in the abdomen. 1 to 10 ml of interstitial liquid will be collected. A sample will be taken on D1 and D2. | Biological | control, septic shock |
| blood samplingA blood sample (3 x 5 ml EDTA tubes) will be taken simultaneously. A sample will be taken on D1 and D2 | Biological | control, septic shock |
Primary outcome
concentration of the differents components of the extracellular matrix on interstitial liquid at Day 1
Time frame: on Day 1
Composition of the extracellular matrix on interstitial liquid on Day 1 (day of the first sampling) for the : * Type(s) of collagen by ELISA technique on 5L of liquid * Identification and quantification of interstitial glycosaminoglycans
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interstitial Liquid and Septic Shock, run by Centre Hospitalier Universitaire Dijon 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 22 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of the differents components of the extracellular matrix on interstitial liquid at Day 1 (time frame: on 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 22 Dec 2025.