Clinical trial NCT04870892: Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock
Official title: Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: septic shock
capillary refill time
norepinephrine
fluid infusion
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with septic shock, cardiac output monitoring device with the PICCO2 system

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

Detailed description: An interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. This last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group.

The strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. This is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered.

However, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.

Eligibility criteria: Inclusion Criteria:

* Septic shock
* Presence of a cardiac output monitoring device with the PICCO2 system (Pulsion Medical Systems, Feldkirchen, Germany)
* Decision by the physician in charge to perform vascular filling or modification the norepinephrine dose

Exclusion Criteria:

* Pregnant
* Patient under a tutelage measure or placed under judicial protection

Primary outcomes:
measure: Difference of capillary refill time before and after the therapeutic change
timeFrame: 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:
measure: Correlation between capillary refill time and perfusion index
timeFrame: 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
measure: Least significant change of capillary refill time
timeFrame: 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
measure: Difference between capillary refill time on thorax and on the index finger tip
timeFrame: 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
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Medical Intensive Care Unit
Study officials:
affiliation: Service de Médecine Intensive - Réanimation, Hôpital Bicêtre, AP-HP
name: Xavier Monnet, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: