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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04870892
Other study ID # 2021-A00624-37
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2021
Source Bicetre Hospital
Contact Xavier Monnet, MD-PhD
Phone +33-(0)6660862669
Email xavier.monnet@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Medical Intensive Care Unit Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor Collaborator
Bicetre Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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