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Usefulness of Capillary Refill Time and Skin Mottling Score to Predict Intensive Care Unit Admission (TRCMARBSAU)

H

Hôpital Necker-Enfants Malades

Status

Unknown

Conditions

Shock, Hemorrhagic
Shock, Septic

Treatments

Other: Capillary refill time and skin mottling score measurement at the admission to the emergency department

Study type

Observational

Funder types

Other

Identifiers

NCT03831022
2018-A02588-47

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age > 18 years

  2. 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:

    1. Systolic blood pressure < 90mmHg or blood pressure decrease of 30% at least for patients with high blood pressure history
    2. Heart rate > 120 beats per minute
    3. Respiratory rate > 22 movements per minute
    4. Glasgow coma scale < 13.

Exclusion criteria

  1. Age < 18 years
  2. Pregnancy
  3. Serious co morbid conditions with a not to be reanimated status known at the ED admission
  4. Patients with guardianship or curator

Trial contacts and locations

1

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Central trial contact

Benoit Vivien, MD, PhD; Romain Jouffroy, MD

Data sourced from clinicaltrials.gov

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