Evaluation of Resuscitation Markers in Trauma Patients

Andrea Campos-Serra

Status: Completed

Conditions: Hypovolemic Shock; Trauma

Treatments: Other: Near-infrared spectroscopy; Other: Blood Lactate; Other: Blood B-type Natriuretic Peptide; Other: Blood Base Excess; Other: Blood Thromboelastometry (ROTEM); Other: Sublingual videomicroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT02772653

CSPT-CG-PPT1

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

66 participants in 1 patient group

Severe trauma patients

Description:

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.

Treatment:

Other: Near-infrared spectroscopy

Other: Sublingual videomicroscopy

Other: Blood Lactate

Other: Blood Base Excess

Other: Blood B-type Natriuretic Peptide

Other: Blood Thromboelastometry (ROTEM)