Clinical trial NCT03831022: Usefulness of Capillary Refill Time and Skin Mottling Score to Predict Intensive Care Unit Admission
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock, Septic
Shock, Hemorrhagic
Keywords: shock
sepsis
haemoragy
intensive care unit
prediction
Lead sponsor: Hôpital Necker-Enfants Malades
Sponsor class: OTHER
Collaborators: name: Hôpital Cochin
name: University Grenoble Alps
name: University Hospital, Strasbourg, France
name: Poitiers University Hospital
name: Begin Military Hospital
name: Argenteuil Hospital
name: University Hospital, Limoges
name: University Hospital, Marseille
First posted: 2019-02-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ED for septic or haemorrhagic shock

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.

Eligibility 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

Primary outcomes:
measure: Rate of ICU admission after ED.
timeFrame: 2 days
Secondary outcomes:
measure: Mortality on day 30 after hospital admission
timeFrame: 30 days
measure: Mortality on day 90 after hospital admission
timeFrame: 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker enfants malades Hospital
state: Ile De France
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.