NCT03831022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

February 3, 2019

Last Update Submit

February 4, 2019

Conditions

Shock, SepticShock, Hemorrhagic

Keywords

shocksepsishaemoragyintensive care unitprediction

Outcome Measures

Primary Outcomes (1)

  • Rate of ICU admission after ED.

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

    2 days

Secondary Outcomes (2)

  • Mortality on day 30 after hospital admission

    30 days

  • Mortality on day 90 after hospital admission

    90 days

Interventions

Capillary refill time and skin mottling score measurement at the admission to the emergency departmentOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the ED for septic or haemorrhagic shock

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker enfants malades Hospital

Paris, Île-de-France Region, 75015, France

RECRUITING

Related Publications (9)

  • Pottecher T, Calvat S, Dupont H, Durand-Gasselin J, Gerbeaux P; SFAR/SRLF workgroup. Haemodynamic management of severe sepsis: recommendations of the French Intensive Care Societies (SFAR/SRLF) Consensus Conference, 13 October 2005, Paris, France. Crit Care. 2006;10(4):311. doi: 10.1186/cc4965.

    PMID: 16941754BACKGROUND

  • Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

    PMID: 8844239BACKGROUND

  • Pickard A, Karlen W, Ansermino JM. Capillary refill time: is it still a useful clinical sign? Anesth Analg. 2011 Jul;113(1):120-3. doi: 10.1213/ANE.0b013e31821569f9. Epub 2011 Apr 25.

    PMID: 21519051BACKGROUND

  • Ait-Oufella H, Bige N, Boelle PY, Pichereau C, Alves M, Bertinchamp R, Baudel JL, Galbois A, Maury E, Guidet B. Capillary refill time exploration during septic shock. Intensive Care Med. 2014 Jul;40(7):958-64. doi: 10.1007/s00134-014-3326-4. Epub 2014 May 9.

    PMID: 24811942BACKGROUND

  • Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.

    PMID: 21373821BACKGROUND

  • Lima A, Jansen TC, van Bommel J, Ince C, Bakker J. The prognostic value of the subjective assessment of peripheral perfusion in critically ill patients. Crit Care Med. 2009 Mar;37(3):934-8. doi: 10.1097/CCM.0b013e31819869db.

    PMID: 19237899BACKGROUND

  • Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.

    PMID: 29176794BACKGROUND

  • Mrgan M, Rytter D, Brabrand M. Capillary refill time is a predictor of short-term mortality for adult patients admitted to a medical department: an observational cohort study. Emerg Med J. 2014 Dec;31(12):954-8. doi: 10.1136/emermed-2013-202925. Epub 2013 Sep 17.

    PMID: 24045049BACKGROUND

  • Jouffroy R, Saade A, Tourtier JP, Gueye P, Bloch-Laine E, Ecollan P, Carli P, Vivien B. Skin mottling score and capillary refill time to assess mortality of septic shock since pre-hospital setting. Am J Emerg Med. 2019 Apr;37(4):664-671. doi: 10.1016/j.ajem.2018.07.010. Epub 2018 Jul 6.

    PMID: 30001815BACKGROUND

MeSH Terms

Conditions

Shock, SepticShock, HemorrhagicShockSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhage

Central Study Contacts

Romain Jouffroy, MD

CONTACT

+33144495989romain.jouffroy@gmail.com

Benoit Vivien, MD, PhD

CONTACT

+33144492424benoit.vivien@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 3, 2019

First Posted

February 5, 2019

Study Start

December 17, 2018

Primary Completion

December 17, 2020

Study Completion

December 17, 2020

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

FR(1)