Evaluation of Resuscitation Markers in Trauma Patients

NCT02772653 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2019-05-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Blood Lactate

Analyzed at the 1rst, 8th and 24th hour from hospital admission

OTHER

Blood Base Excess

Analyzed at the 1rst, 8th and 24th hour from hospital admission

OTHER

Blood B-type Natriuretic Peptide

Analyzed at the 1rst, 8th and 24th hour from hospital admission

OTHER

Blood Thromboelastometry (ROTEM)

Analyzed at the 1rst, 8th and 24th hour from hospital admission

OTHER

Near-infrared spectroscopy

Analyzed at the 1rst, 8th and 24th hour from hospital admission

OTHER

Sublingual videomicroscopy

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Sponsors & Collaborators

  • Corporacion Parc Tauli

    collaborator OTHER
  • Andrea Campos-Serra

    lead OTHER

Principal Investigators

  • Andrea Campos-Serra, MD · Corporacion Sanitaria Parc Tauli

  • Salvador Navarro-Soto, MD, PhD · Corporacion Sanitaria Parc Tauli

  • Sandra Montmany-Vioque, MD, PhD · Corporacion Sanitaria Parc Tauli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-03-26
Completion
2019-03-26

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772653 on ClinicalTrials.gov