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

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

Detailed Description
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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.

Official Title
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Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock

Conditions
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Septic Shock

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Norepinephrine variation<br>Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to modify the norepinephrine dose. | |
| Fluid infusion<br>Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to give fluid infusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of capillary refill time before and after the therapeutic change | Capillary refill time 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between capillary refill time and perfusion index | Capillary refill time 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 | 
| Least significant change of capillary refill time | Capillary refill time 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 | 
| Difference between capillary refill time on thorax and on the index finger tip | Capillary refill time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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norepinephrine, fluid infusion, septic shock, capillary refill time