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Shock, SepticTRCMARBSAUNCT03831022

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

An observational study of Shock, Septic and Shock, Hemorrhagic, run by Hôpital Necker-Enfants Malades at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Septic, Shock, Hemorrhagic
What is being tested?
Capillary refill time and skin mottling score measurement at the admission to the emergency department
How many people
1,500 participants
Where
1 siteFrance
Study dates
17 Dec 2018to 17 Dec 2020
How long will I take part?
90 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to the ED for septic or haemorrhagic shock

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Romain Jouffroy, MD contact

+33144495989

romain.jouffroy@gmail.com

Benoit Vivien, MD, PhD contact

+33144492424

benoit.vivien@aphp.fr

France1 site, 1 recruiting

  • Necker enfants malades Hospital

    Paris, Île-de-France Region, 75015

    Romain Jouffroy, MD, +33144495989, romain.jouffroy@gmail.com

    Benoit Vivien, MD, PhD, +33144492424, benoit.vivien@aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Capillary refill time and skin mottling score measurement at the admission to the emergency department
Keywords
shock, sepsis, haemoragy, intensive care unit, prediction
Medical subject headings
Shock, Septic, Shock, Hemorrhagic, Shock, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of ICU admission after ED.

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

    Measured: 2 days

Secondary outcomes (2)

  1. Mortality on day 30 after hospital admission

    The vital status (alive or deceased) will be recorded on day 30 after hospital admission

    Measured: 30 days

  2. Mortality on day 90 after hospital admission

    The vital status (alive or deceased) will be recorded on day 90 after hospital admission

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2019
  2. Study start17 Dec 2018
  3. Primary completion17 Dec 2020 (estimated)
  4. Study completion17 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03831022
Sponsor's protocol ID
2018-A02588-47
Acronym
TRCMARBSAU
Status last verified
Feb 2019
First submitted
3 Feb 2019
Last updated
6 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 16941754

  • 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.

    PubMed 8844239

  • 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.

    PubMed 21519051

  • 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.

    PubMed 24811942

  • 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.

    PubMed 21373821

  • 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.

    PubMed 19237899

  • 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.

    PubMed 29176794

  • 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.

    PubMed 24045049

  • 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.

    PubMed 30001815

Questions about this trial

What is this clinical trial studying?

An observational study of Shock, Septic and Shock, Hemorrhagic, run by Hôpital Necker-Enfants Malades at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Romain Jouffroy, MD (+33144495989, romain.jouffroy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of ICU admission after ED. (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03831022, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.

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