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

Shock, Septic Clinical Trial

— TRCMARBSAU  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831022
• Other study ID #: 2018-A02588-47
• Status: Recruiting
• Start date: December 17, 2018
• Est. completion date: December 17, 2020

Study information

• Verified date: February 2019
• Source: Hôpital Necker-Enfants Malades
• Contact: Romain Jouffroy, MD
• Phone: +33144495989
• Email: romain.jouffroy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 17, 2020
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Hemorrhagic
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
France	Necker enfants malades Hospital	Paris	Ile De France

Sponsors (9)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades	Argenteuil Hospital, Begin Military Hospital, Hôpital Cochin, Marseille University Hospital, Poitiers University Hospital, Strasbourg University Hospital, University Grenoble Alps, University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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. — View 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. 2018 Jul 6. pii: S0735-6757(18)30567-9. doi: 10.1016/j.ajem.2018.07.010. [Epub ahead of print] — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ICU admission after ED.	The rate of ICU admission after ED will be monitored for each patient	2 days
Secondary	Mortality on day 30 after hospital admission	The vital status (alive or deceased) will be recorded on day 30 after hospital admission	30 days
Secondary	Mortality on day 90 after hospital admission	The vital status (alive or deceased) will be recorded on day 90 after hospital admission	90 days