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

February 4, 2019 updated by: Romain Jouffroy, Hôpital Necker-Enfants Malades

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75015
        • Recruiting
        • Necker Enfants malades hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanuel Bloch-Laine, MD
        • Principal Investigator:
          • Pierrick Le Borgne, MD, PhD
        • Principal Investigator:
          • Maxime Maignan, MD, PhD
        • Principal Investigator:
          • Nicolas MARJANOVIC, MD
        • Principal Investigator:
          • Thomas Lafon, MD
        • Principal Investigator:
          • Léa Thomas, MD
        • Principal Investigator:
          • Scarlett Dehdar, MD
        • Principal Investigator:
          • Pierre Michelet, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the ED for septic or haemorrhagic shock

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ICU admission after ED.
Time Frame: 2 days
The rate of ICU admission after ED will be monitored for each patient
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality on day 30 after hospital admission
Time Frame: 30 days
The vital status (alive or deceased) will be recorded on day 30 after hospital admission
30 days
Mortality on day 90 after hospital admission
Time Frame: 90 days
The vital status (alive or deceased) will be recorded on day 90 after hospital admission
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Necker-Enfants Malades

Collaborators

University Hospital, Strasbourg, France
Poitiers University Hospital
University Hospital, Limoges
Hôpital Cochin
University Hospital, Marseille
University Grenoble Alps
Begin Military Hospital
Argenteuil Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Anticipated)

December 17, 2020

Study Completion (Anticipated)

December 17, 2020

Study Registration Dates

First Submitted

February 3, 2019

First Submitted That Met QC Criteria

February 3, 2019

First Posted (Actual)

February 5, 2019

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02588-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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