Sepsis Clinical Trial
— REPTILOSOfficial title:
Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
NCT number | NCT05094856 |
Other study ID # | APHP210918 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 23, 2022 |
Est. completion date | March 16, 2023 |
Verified date | June 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 61 |
Est. completion date | March 16, 2023 |
Est. primary completion date | February 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Intensive care department, Hôpital Saint Antoine | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Grifols (funder), Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 hour | |
Secondary | CRT Measure | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock. | 4 hours | |
Secondary | mottling score measure | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 4 hours | |
Secondary | Diuresis | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 4 hours | |
Secondary | Variations in cardiac flow | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 4 hours | |
Secondary | 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 |
4 hours |
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