Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock in Angers University Hospital

NCT05325957 | Withdrawn DMC

• 1 other identifier: 49RC22_0096
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

the purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Difference of capillary refill time before and after the therapeutic change

  Capillary refill time (CRT) is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera.

  Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose

Secondary Outcomes (3)

• Correlation between capillary refill time and perfusion index

  Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose

• Least significant change of capillary refill time

  Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose

• Difference between capillary refill time on thorax and on the index finger tip

  Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose

Study Arms (2)

Norepinephrine variation

Patients with septic shock, cardiac output monitoring device with the PICCO2 system or swan ganz catheter and decision by the physician in charge to modify the norepinephrine dose.

Fluid infusion

Patients with septic shock, cardiac output monitoring device with the PICCO2 system or swan ganz catheter and decision by the physician in charge to give fluid infusion

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 septic shock, cardiac output monitoring device with the PICCO2 system or swan ganz catheter

You may qualify if:

• Septic shock
• Presence of a cardiac output monitoring
• Decision by the physician in charge to perform vascular filling or modification the norepinephrine dose

You may not qualify if:

• Patient under a tutelage measure or placed under judicial protection

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Medical Intensive Care Unit

Angers, Maine-et-Loire, 49100, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre ASFAR, M.D- Ph.D

  Angers CHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: May 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

FR (1)