Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock

NCT05094856 | Completed

• 1 other identifier: APHP210918
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Septic Shock; Sepsis

Keywords

Endothelial dysfunction; Albumin; Fluid Therapy; Peripheral Tissue Perfusion; Septic shock; Microcirculatory effects; Hemodynamic effects; sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• CRT Measure

  4 hours

• mottling score measure

  4 hours

• Diuresis

  4 hours

• Variations in cardiac flow

  4 hours

• Variations in the biological parameters

  4 hours

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Grifols (funder): collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Intensive care department, Hôpital Saint Antoine

Paris, 75012, France

Location

Related Publications (1)

• 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.

  PMID: 38326920 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Hafid AIT-OUFELLA

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: October 26, 2021
• Study Start: February 23, 2022
• Primary Completion: February 16, 2023
• Study Completion: March 16, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)