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Clinical Trials/NCT03831022
NCT03831022
Unknown
Not Applicable

Contribution of Capillary Refilling Time and Skin Mottling Score to Predict Intensive Care Unit Admission of Patients With Septic or Haemorrhagic Shock Admitted to the Emergency Department

Hôpital Necker-Enfants Malades1 site in 1 country1,500 target enrollmentDecember 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shock, Septic
Sponsor
Hôpital Necker-Enfants Malades
Enrollment
1500
Locations
1
Primary Endpoint
Rate of ICU admission after ED.
Last Updated
7 years ago

Overview

Brief Summary

In the emergency department (ED), the severity assessment of shock is a fundamental step prior to the admission in intensive care unit (ICU). As biomarkers are time consuming to evaluate severity of the micro and macro-circulation alteration, capillary refill time and skin mottling score are 2 simples, available clinical criteria validated to predict mortality in the ICU.

The aim of this study is to provide clinical evidence that capillary refill time and skin mottling score assessed in the ED also predict ICU admission of patients with septic or haemorrhagic shock.

Detailed Description

This trial is an observational, non-randomized controlled study. A total of 1500 patients admitted to the ED for a septic or hemorrhagic shock will be followed. The primary outcome is the admission to the ICU. The study will not impact the treatments provided to each patient. Capillary refill time and skin mottling score will not be taken into account to decide patient's treatments and/or ICU admission. Patients will be followed during their hospital stay in order to precise their destination after ED (home, ICU, ward) and 28- and 90-days mortality after hospital admission.

Registry
clinicaltrials.gov
Start Date
December 17, 2018
End Date
December 17, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hôpital Necker-Enfants Malades
Responsible Party
Principal Investigator
Principal Investigator

Romain Jouffroy

MD

Hôpital Necker-Enfants Malades

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years
  • Skin mottling score\> 2 and/or capillary refill time \> 3secondes associated with at least one of the followings measured at the ED admission by the nurse in charge of the patient:
  • Systolic blood pressure \< 90mmHg or blood pressure decrease of 30% at least for patients with high blood pressure history
  • Heart rate \> 120 beats per minute
  • Respiratory rate \> 22 movements per minute
  • Glasgow coma scale \< 13.

Exclusion Criteria

  • Age \< 18 years
  • Serious co morbid conditions with a not to be reanimated status known at the ED admission
  • Patients with guardianship or curator

Outcomes

Primary Outcomes

Rate of ICU admission after ED.

Time Frame: 2 days

The rate of ICU admission after ED will be monitored for each patient

Secondary Outcomes

  • Mortality on day 90 after hospital admission(90 days)
  • Mortality on day 30 after hospital admission(30 days)

Study Sites (1)

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