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

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ClinicalTrials.gov Identifier: NCT03831022
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Hôpital Cochin
University Grenoble Alps
Strasbourg University Hospital
Poitiers University Hospital
Begin Military Hospital
Argenteuil Hospital
University Hospital, Limoges
Marseille University Hospital
Information provided by (Responsible Party):
Romain Jouffroy, 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.


Condition or disease Intervention/treatment
Shock, Septic Shock, Hemorrhagic Other: Capillary refill time and skin mottling score measurement at the admission to the emergency department

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: 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
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : December 17, 2020
Estimated Study Completion Date : December 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock


Intervention Details:
  • Other: Capillary refill time and skin mottling score measurement at the admission to the emergency department
    Patients who meet the inclusion criteria and none of the non-inclusion criteria will benefit from capillary refill time and skin mottling score measurement at the admission to the emergency department (ED) and followed during their hospital stay to precise the destination after ED (home, ICU, ward) and 30- and 90-days mortality after hospital admission.


Primary Outcome Measures :
  1. Rate of ICU admission after ED. [ Time Frame: 2 days ]
    The rate of ICU admission after ED will be monitored for each patient


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ED for septic or haemorrhagic shock
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831022


Contacts
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Contact: Romain Jouffroy, MD +33144495989 romain.jouffroy@gmail.com
Contact: Benoit Vivien, MD, PhD +33144492424 benoit.vivien@aphp.fr

Locations
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France
Necker enfants malades Hospital Recruiting
Paris, Ile De France, France, 75015
Contact: Romain Jouffroy, MD    +33144495989    romain.jouffroy@gmail.com   
Contact: Benoit Vivien, MD, PhD    +33144492424    benoit.vivien@aphp.fr   
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         
Sponsors and Collaborators
Hôpital Necker-Enfants Malades
Hôpital Cochin
University Grenoble Alps
Strasbourg University Hospital
Poitiers University Hospital
Begin Military Hospital
Argenteuil Hospital
University Hospital, Limoges
Marseille University Hospital

Additional Information:

Publications:

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Responsible Party: Romain Jouffroy, MD, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT03831022     History of Changes
Other Study ID Numbers: 2018-A02588-47
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Romain Jouffroy, Hôpital Necker-Enfants Malades:
shock
sepsis
haemoragy
intensive care unit
prediction

Additional relevant MeSH terms:
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Shock
Shock, Septic
Shock, Hemorrhagic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Hemorrhage