Clinical trial NCT02772653: Evaluation of Resuscitation Markers in Trauma Patients
Official title: Evaluation of Resuscitation Markers in Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Hypovolemic Shock
Keywords: Microcirculation
Videomicroscopy
Spectroscopy, Near-Infrared
B-Type Natriuretic Peptide
Thromboelastometry
Trauma
Resuscitation
Hypovolemic shock
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2016-05-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mortality
timeFrame: Through study completion, an average of 1-2 years
Secondary outcomes:
measure: Multiple organ dysfunction (Multiple Organ Dysfunction Score)
timeFrame: Through study completion, an average of 1-2 years
measure: Blood cell transfusion
timeFrame: Through study completion, an average of 1-2 years
measure: Activation of the Massive blood transfusion protocol
timeFrame: At hospital admission
measure: Surgical intervention for bleeding control
timeFrame: Through study completion, an average of 1-2 years
measure: Arteriographic embolization for bleeding control
timeFrame: Through study completion, an average of 1-2 years
Other outcomes:
measure: Hospital stay
timeFrame: Through study completion, an average of 1-2 years
measure: Intensive care unit stay
timeFrame: Through study completion, an average of 1-2 years
Locations:
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Tauli
state: Barcelona
Study officials:
affiliation: Corporacion Sanitaria Parc Tauli
name: Andrea Campos-Serra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacion Sanitaria Parc Tauli
name: Salvador Navarro-Soto, MD, PhD
role: STUDY_DIRECTOR
affiliation: Corporacion Sanitaria Parc Tauli
name: Sandra Montmany-Vioque, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Campos-Serra A, Mesquida J, Montmany-Vioque S, Rebasa-Cladera P, Barquero-Lopez M, Cidoncha-Secilla A, Llorach-Perucho N, Morales-Codina M, Puyana JC, Navarro-Soto S. Alterations in tissue oxygen saturation measured by near-infrared spectroscopy in trauma patients after initial resuscitation are associated with occult shock. Eur J Trauma Emerg Surg. 2023 Feb;49(1):307-315. doi: 10.1007/s00068-022-02068-w. Epub 2022 Sep 2.