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| Name | Class |
|---|---|
| Grifols (funder) | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CRT Measure | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock. | 4 hours |
| mottling score measure | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hafid AIT-OUFELLA | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care department, Hôpital Saint Antoine | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38326920 | Derived | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| 4 hours |
| Diuresis | Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock. | 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. | 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:
| 4 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |