Acute Circulatory FailureINPPEREANCT06384287
Peripheral Tissue Perfusion in Intensive Care
An observational study of Acute Circulatory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Circulatory Failure
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2024to Jul 2027
- 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: Patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring a therapeutic intervention (fluid challenge or vasopressor or dobutamine)
Who may be able to join
- Patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring therapeutic intervention
Who cannot join
- Agitation
- Hemorrhagic shock
- Severe skin lesions
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
Saint -Antoine Hospital_Médecine Intensive Reanimation
Paris, 75012
Hafid Ait-Oufella, +33612011940, hafid.aitoufella@aphp.fr
About this study
Official title: Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care
Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.
The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).
Read the detailed description
Sepsis is today a major cause of morbidity and mortality worldwide. Septic shock, the most serious manifestation of the infection, affects 2 to 20% of intensive care patients. Despite appropriate antibiotic therapy and improved resuscitation strategies based on early treatment, volume expansion and rational use of vasopressors, the mortality rate of shock states remains too high, between 40 and 50%.
Over the past two decades, great advances have been made in the understanding the pathophysiology of septic shock. Microcirculatory abnormalities have been identified as the main cause of organ hypoperfusion and visceral failure leading to death. In addition, several studies in animals and humans have highlighted a discordance between systemic hemodynamic parameters and alterations of small vessels during shock suggesting that microvascular blood flow and tissue perfusion should be analyzed in patients with acute circulatory failure in association with blood pressure and cardiac output. Capillary refill time (CRT), is an easy-to-use, easy-to learn tool to evaluate peripheral tissue perfusion. CRT is a strong predictive factor of organ failure severity and poor outcome in critically ill patients with sepsis. A recent randomized trial reported promising results regarding the use of CRT to guide resuscitation. However, little is known about the impact of treatment on CRT. The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).
- Conditions
- Acute Circulatory Failure
- Keywords
- Tissue perfusion, Capillary refill time, Skin blood flow, Fluid challenge, Inotrope
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fluid challenge | Impact of fluid challenge on peripheral tissue perfusion on sepsis patients | |
| Vasopressors | Impact of vasopressors on peripheral tissue perfusion on sepsis patients | |
| Inotrope | Impact of dobutamine on peripheral tissue perfusion on patients with septic or cardiogenic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin blood flow variations
Measurement using laser doppler probe in the finger tip
Measured: continuous monitoring during 1 hour maximum starting just before intervention
Secondary outcomes (5)
Capillary refill time
Clinical measurement at bedside
Measured: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
Mottling score
Clinical measurement at bedside
Measured: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
correlation between Skin blood flow and CRT (baseline and variations)
Measurement using laser doppler probe in the finger tip
Measured: at baseline, at 10, 30 and 60 minutes after intervention
correlation between skin blood flow and Cardiac output
Laser doppler with skin probe and echocardiography
Measured: at baseline, at 10, 30 and 60 minutes after intervention
correlation between skin blood flow and mean arterial pressure
Laser doppler with skin probe and arterial catheter
Measured: at baseline, at 10, 30 and 60 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 Jun 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Circulatory FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384287
- Sponsor's protocol ID
- APHP231342
- Acronym
- INPPEREA
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Therapeutic Hemodynamic Interventions on Peripheral Perfusion in Intensive Care
- ClinicalTrials.gov ID
- NCT06384287
- Acronym / sponsor ID
- INPPEREA / APHP231342
- Conditions
- Acute Circulatory Failure
- Keywords
- Tissue perfusion, Capillary refill time, Skin blood flow, Fluid challenge, Inotrope
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Apr 2024 (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.
Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.
The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).
Detailed description
Sepsis is today a major cause of morbidity and mortality worldwide. Septic shock, the most serious manifestation of the infection, affects 2 to 20% of intensive care patients. Despite appropriate antibiotic therapy and improved resuscitation strategies based on early treatment, volume expansion and rational use of vasopressors, the mortality rate of shock states remains too high, between 40 and 50%.
Over the past two decades, great advances have been made in the understanding the pathophysiology of septic shock. Microcirculatory abnormalities have been identified as the main cause of organ hypoperfusion and visceral failure leading to death. In addition, several studies in animals and humans have highlighted a discordance between systemic hemodynamic parameters and alterations of small vessels during shock suggesting that microvascular blood flow and tissue perfusion should be analyzed in patients with acute circulatory failure in association with blood pressure and cardiac output. Capillary refill time (CRT), is an easy-to-use, easy-to learn tool to evaluate peripheral tissue perfusion. CRT is a strong predictive factor of organ failure severity and poor outcome in critically ill patients with sepsis. A recent randomized trial reported promising results regarding the use of CRT to guide resuscitation. However, little is known about the impact of treatment on CRT. The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluid challenge | – | –Impact of fluid challenge on peripheral tissue perfusion on sepsis patients |
| Vasopressors | – | –Impact of vasopressors on peripheral tissue perfusion on sepsis patients |
| Inotrope | – | –Impact of dobutamine on peripheral tissue perfusion on patients with septic or cardiogenic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring a therapeutic intervention (fluid challenge or vasopressor or dobutamine)
Key inclusion criteria (1 listed)
- Patients in intensive care unit with acute circulatory failure related to sepsis or cardiac failure requiring therapeutic intervention
Key exclusion criteria (3 listed)
- Agitation
- Hemorrhagic shock
- Severe skin lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin blood flow variations
Time frame: continuous monitoring during 1 hour maximum starting just before intervention
Measurement using laser doppler probe in the finger tip
5 secondary outcomes
Capillary refill time
Time frame: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
Mottling score
Time frame: at baseline, 3 timepoints after starting interventions (10, 30 and 60 minutes)
correlation between Skin blood flow and CRT (baseline and variations)
Time frame: at baseline, at 10, 30 and 60 minutes after intervention
correlation between skin blood flow and Cardiac output
Time frame: at baseline, at 10, 30 and 60 minutes after intervention
correlation between skin blood flow and mean arterial pressure
Time frame: at baseline, at 10, 30 and 60 minutes after intervention
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 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Circulatory Failure
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
RecruitingObservational study
Exploratory Study on Bio-signal Telemonitoring Using Electronic Textiles in a Pediatric Acute and Critical Care Setting
Heart Failure
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 Acute Circulatory Failure, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 3 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 2 Sep 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?
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 Hafid Ait-Oufella (+33612011940, hafid.aitoufella@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin blood flow variations (time frame: continuous monitoring during 1 hour maximum starting just before intervention). 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 2 Sep 2025.