Septic ShockREPTILOSNCT05094856
Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock
An observational study of Septic Shock and Sepsis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2022to 16 Mar 2023
- 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: Patients with sepsis/septic shock hospitalized in intensive care with signs of peripheral hypoperfusion persisting despite the initial resuscitation. Septic shock corresponds to patients with sepsis (infection + 2 SOFA points according to the latest international definition and the need to administer noradrenaline to maintain mean arterial pressure> 65 mmHg. In total, patients with reanimated and hemodynamically stabilized sepsis/septic shock will be included. The diagnostic and therapeutic management will comply in all points with the usual service protocol and international recommendations.
Who may be able to join
- Age> 18 years old
- Sepsis or
- Septic shock within 24 hours of admission to intensive care with a stable dose of norepinephrine for at least 2 hours to maintain MAP> 65mmHg
- CRT index> 3 seconds despite the initial resuscitation (administration of antibiotics, volume expansion by crystalloids of 20 mL / Kg, noradrenaline started) between the admission to intensive care and H48 from admission to intensive care
- Non-opposition of the patient collected by the doctor in charge of the patient between H0 and H6 after admission if the patient is vigilant, otherwise a procedure for collecting non-opposition from relatives will be carried out with collection of the non-opposition of the patient once he is able to give it.
- Affiliation to a social security regimen (excluding AME)
Who cannot join
- Patient COVID-19 (+) with respiratory impairment
- Pregnant and lactating woman
- Patient under Guardianship / Curatorship
- Refusal to participate
- CRT not evaluable (dark or damaged skin)
- Moribund patient
- Estimated life expectancy less than 1 month
- Participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
Read the detailed description
This is a transversal study allowing to compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion
Design:
- A multicentric, open-label, transversal study
Sample size :
60 patients
Assessement:
Between the admission to intensive care and 48 hours after admission, the patient will be included after collection of the non-opposition form.
The patient will receive volume expansion either by 0.9% saline (500mL) or by 20% albumin (100mL) over 15 minutes.
Repeated clinical measurements will be performed at H0, H0.5 and H1 (respectively at 0, 30 and 60 minutes).
A blood sample will be taken just before the volume expansion and 4 hours after, at the same time as the samples usually taken as part of the treatment.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.
- Conditions
- Septic Shock, Sepsis
- Keywords
- Endothelial dysfunction, Albumin, Fluid Therapy, Peripheral Tissue Perfusion, Septic shock, Microcirculatory effects, Hemodynamic effects, sepsis
- Medical subject headings
- Shock, Septic, Sepsis
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 |
|---|---|---|
| Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion | Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion by measuring the proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice. | |
| Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion | Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion by measuring the proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
Proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.
Measured: 1 hour
Secondary outcomes (5)
CRT Measure
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock.
Measured: 4 hours
mottling score measure
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.
Measured: 4 hours
Diuresis
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.
Measured: 4 hours
Variations in cardiac flow
Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.
Measured: 4 hours
Variations in the biological parameters
Variations in the biological parameters between H0 and H4 will be analyzed from 5 ml of blood taken in addition, in accordance with the usual practice, in a sepsis/septic shock:
- IL-6, IL-1b, Il-8, TNFa, IL-10
- Syndecan-1, heparan sulfat, hyaluronat
- Circulating microparticles
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start23 Feb 2022
- Primary completion16 Feb 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols (funder), Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Hafid AIT-OUFELLA, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094856
- Sponsor's protocol ID
- APHP210918
- Acronym
- REPTILOS
- Status last verified
- Jun 2024
- First submitted
- 31 Jul 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gabarre P, Desnos C, Morin A, Missri L, Urbina T, Bonny V, Turpin M, Baudel JL, Berard L, Montil M, Guidet B, Voiriot G, Joffre J, Maury E, Ait-Oufella H. Albumin versus saline infusion for sepsis-related peripheral tissue hypoperfusion: a proof-of-concept prospective study. Crit Care. 2024 Feb 7;28(1):43. doi: 10.1186/s13054-024-04827-0.
PubMed 38326920
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
- ClinicalTrials.gov ID
- NCT05094856
- Acronym / sponsor ID
- REPTILOS / APHP210918
- Conditions
- Septic Shock, Sepsis
- Keywords
- Endothelial dysfunction, Albumin, Fluid Therapy, Peripheral Tissue Perfusion, Septic shock, Microcirculatory effects, Hemodynamic effects, sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Grifols (funder), Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 26 Oct 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.
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
Detailed description
This is a transversal study allowing to compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion
Design:
- A multicentric, open-label, transversal study
Sample size :
60 patients
Assessement:
Between the admission to intensive care and 48 hours after admission, the patient will be included after collection of the non-opposition form.
The patient will receive volume expansion either by 0.9% saline (500mL) or by 20% albumin (100mL) over 15 minutes.
Repeated clinical measurements will be performed at H0, H0.5 and H1 (respectively at 0, 30 and 60 minutes).
A blood sample will be taken just before the volume expansion and 4 hours after, at the same time as the samples usually taken as part of the treatment.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion | – | –Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion by measuring the proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice. |
| Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion | – | –Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion by measuring the proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis/septic shock hospitalized in intensive care with signs of peripheral hypoperfusion persisting despite the initial resuscitation. Septic shock corresponds to patients with sepsis (infection + 2 SOFA points according to the latest international definition and the need to administer noradrenaline to maintain mean arterial pressure> 65 mmHg. In total, patients with reanimated and hemodynamically stabilized sepsis/septic shock will be included. The diagnostic and therapeutic management will comply in all points with the usual service protocol and international recommendations.
Key inclusion criteria (6 listed)
- Age> 18 years old
- Sepsis or
- Septic shock within 24 hours of admission to intensive care with a stable dose of norepinephrine for at least 2 hours to maintain MAP> 65mmHg
- CRT index> 3 seconds despite the initial resuscitation (administration of antibiotics, volume expansion by crystalloids of 20 mL / Kg, noradrenaline started) between the admission to intensive care and H48 from admission to intensive care
- Non-opposition of the patient collected by the doctor in charge of the patient between H0 and H6 after admission if the patient is vigilant, otherwise a procedure for collecting non-opposition from relatives will be carried out with collection of the non-opposition of the patient once he is able to give it.
Key exclusion criteria (8 listed)
- Patient COVID-19 (+) with respiratory impairment
- Pregnant and lactating woman
- Patient under Guardianship / Curatorship
- Refusal to participate
- CRT not evaluable (dark or damaged skin)
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
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
Time frame: 1 hour
Proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value <3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.
5 secondary outcomes
CRT Measure
Time frame: 4 hours
mottling score measure
Time frame: 4 hours
Diuresis
Time frame: 4 hours
Variations in cardiac flow
Time frame: 4 hours
Variations in the biological parameters
Time frame: 4 hours
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 7 Jun 2024.
- Derived from this study: PubMed 38326920Gabarre P, Desnos C, Morin A, Missri L, Urbina T, Bonny V, Turpin M, Baudel JL, Berard L, Montil M, Guidet B, Voiriot G, Joffre J, Maury E, Ait-Oufella H. Albumin versus saline infusion for sepsis-related peripheral tissue hypoperfusion: a proof-of-concept prospective study. Crit Care. 2024 Feb 7;28(1):43. doi: 10.1186/s13054-024-04827-0.
- Individual participant dataSharing planned: Undecided
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Sepsis
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.
Hafid AIT-OUFELLA principal investigator
Assistance Publique - Hôpitaux de Paris
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 Septic Shock and Sepsis, 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 6 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 7 Jun 2024. 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?
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1 (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094856, which also lists 1 linked publication.
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 7 Jun 2024.