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

B

Bicetre Hospital

Status

Unknown

Conditions

Septic Shock

Study type

Observational

Funder types

Other

Identifiers

NCT04870892
2021-A00624-37

Details and patient eligibility

About

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

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

64 participants in 2 patient groups

Norepinephrine variation
Description:
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
Description:
Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to give fluid infusion

Trial contacts and locations

1

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Central trial contact

Nicolas Fage, MSC; Xavier Monnet, MD-PhD

Data sourced from clinicaltrials.gov

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