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Evaluation of Resuscitation Markers in Trauma Patients

11. mai 2019 oppdatert av: Andrea Campos-Serra

Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.

This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

66

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
    • Barcelona
      • Sabadell, Barcelona, Spania, 08208
        • Corporación Sanitaria Parc Taulí

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli

Beskrivelse

Inclusion Criteria:

  • Pre-hospital Priority 0 protocol activation:
  • Glasgow coma scale < 14
  • Systolic blood pressure < 90 mmHg
  • Respiratory rate < 10 or > 29 breaths per minute
  • Absent peripheral pulses
  • Pre-hospital Priority 1 protocol activation:
  • All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
  • Flail chest
  • Two or more proximal long-bone fractures
  • Crushed, degloved or mangled extremity
  • Amputation proximal to wrist and ankle
  • Pelvic fracture
  • Open or depressed skull fracture
  • Paralysis

Exclusion Criteria:

  • Hospitalization < 24 hours ( transport of the patient to an other trauma center)
  • Patients transported from an other hospital (first hours of medical support done elsewhere)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Severe trauma patients

No interventions are done. It's a prospective and descriptive observational study where different markers are analyzed:

  • Blood Lactate levels
  • Blood Base Excess levels
  • Blood B-type Natriuretic Peptide levels
  • Blood Thromboelastometry (ROTEM) alterations
  • Near-infrared spectroscopy alterations
  • Sublingual videomicroscopy alterations

All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission.
Annen: Blood Lactate
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Annen: Blood Base Excess
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Annen: Blood B-type Natriuretic Peptide
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Annen: Blood Thromboelastometry (ROTEM)
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Annen: Near-infrared spectroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Annen: Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality
Tidsramme: Through study completion, an average of 1-2 years
Death of the patient
Through study completion, an average of 1-2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
Tidsramme: Through study completion, an average of 1-2 years
Marshall's score (MODS Score) consist on the analysis of 6 systems through different descriptors, those descriptors include: a) the respiratory system (pO2/FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirrubine concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale); and f) the cardiovascular system (pressure adjusted heart rate). The cardiovascular system descriptor is calculated as the product of the heart rate and the ratio of central venous pressure to mean arterial pressure. All these descriptors will be measured during the first 24h from hospital admission.
Through study completion, an average of 1-2 years
Blood cell transfusion
Tidsramme: Through study completion, an average of 1-2 years
Need for blood cell transfusion for patients
Through study completion, an average of 1-2 years
Activation of the Massive blood transfusion protocol
Tidsramme: At hospital admission
Need for massive transfusion protocol activation on patients with suspicion of active bleeding
At hospital admission
Surgical intervention for bleeding control
Tidsramme: Through study completion, an average of 1-2 years
Need for surgical control on patients with active bleeding
Through study completion, an average of 1-2 years
Arteriographic embolization for bleeding control
Tidsramme: Through study completion, an average of 1-2 years
Need for arteriographic embolization on patients with active bleeding
Through study completion, an average of 1-2 years

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hospital stay
Tidsramme: Through study completion, an average of 1-2 years
Number of days that the patient remains in hospital
Through study completion, an average of 1-2 years
Intensive care unit stay
Tidsramme: Through study completion, an average of 1-2 years
Number of days that the patient remains in the intensive care unit
Through study completion, an average of 1-2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Andrea Campos-Serra

Samarbeidspartnere

Corporacion Parc Tauli

Etterforskere

  • Hovedetterforsker: Andrea Campos-Serra, MD, Corporación Sanitaria Parc Taulí
  • Studieleder: Salvador Navarro-Soto, MD, PhD, Corporación Sanitaria Parc Taulí
  • Studieleder: Sandra Montmany-Vioque, MD, PhD, Corporación Sanitaria Parc Taulí

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2016

Primær fullføring (Faktiske)

26. mars 2019

Studiet fullført (Faktiske)

26. mars 2019

Datoer for studieregistrering

Først innsendt

7. mai 2016

Først innsendt som oppfylte QC-kriteriene

12. mai 2016

Først lagt ut (Anslag)

13. mai 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CSPT-CG-PPT1

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