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Evaluation of Resuscitation Markers in Trauma Patients

11. maj 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

66

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Andet: Blood Lactate
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Andet: Blood Base Excess
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Andet: Blood B-type Natriuretic Peptide
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Andet: Blood Thromboelastometry (ROTEM)
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Andet: Near-infrared spectroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Andet: Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Andrea Campos-Serra

Samarbejdspartnere

Corporacion Parc Tauli

Efterforskere

  • Ledende efterforsker: 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2016

Primær færdiggørelse (Faktiske)

26. marts 2019

Studieafslutning (Faktiske)

26. marts 2019

Datoer for studieregistrering

Først indsendt

7. maj 2016

Først indsendt, der opfyldte QC-kriterier

12. maj 2016

Først opslået (Skøn)

13. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CSPT-CG-PPT1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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