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

• Conditions: Shock, Septic; Shock, Hemorrhagic

• Registration Number: NCT03831022
• Lead Sponsor: Hôpital Necker-Enfants Malades

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.

Study Timeline

• Study Start: 2018-12-17
• Status Verified: 2019-02
• Study First Submitted: 2019-02-03
• Study First Submitted QC: 2019-02-03
• Last Update Submitted: 2019-02-04
• Study First Posted: 2019-02-05
• Last Update Posted: 2019-02-06
• Primary Completion: 2020-12-17
• Study Completion: 2020-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of ICU admission after ED.	2 days	The rate of ICU admission after ED will be monitored for each patient

Secondary Outcome Measures

Name	Time	Method
Mortality on day 90 after hospital admission	90 days	The vital status (alive or deceased) will be recorded on day 90 after hospital admission
Mortality on day 30 after hospital admission	30 days	The vital status (alive or deceased) will be recorded on day 30 after hospital admission

Trial Locations

Locations (1)

Necker enfants malades Hospital; 🇫🇷 Paris, Ile De France, France