Evaluation of Resuscitation Markers in Trauma Patients

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Hypovolemic Shock
• Intervention / Treatment: Other: Blood Lactate; Other: Blood Base Excess; Other: Blood B-type Natriuretic Peptide; Other: Blood Thromboelastometry (ROTEM); Other: Near-infrared spectroscopy; Other: Sublingual videomicroscopy

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacion Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death of the patient	Through study completion, an average of 1-2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multiple organ dysfunction (Multiple Organ Dysfunction Score)	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	Need for blood cell transfusion for patients	Through study completion, an average of 1-2 years
Activation of the Massive blood transfusion protocol	Need for massive transfusion protocol activation on patients with suspicion of active bleeding	At hospital admission
Surgical intervention for bleeding control	Need for surgical control on patients with active bleeding	Through study completion, an average of 1-2 years
Arteriographic embolization for bleeding control	Need for arteriographic embolization on patients with active bleeding	Through study completion, an average of 1-2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Number of days that the patient remains in hospital	Through study completion, an average of 1-2 years
Intensive care unit stay	Number of days that the patient remains in the intensive care unit	Through study completion, an average of 1-2 years

Collaborators and Investigators

• Sponsor: Andrea Campos-Serra
• Collaborators: Corporacion Parc Tauli
• Investigators: Principal Investigator: Andrea Campos-Serra, MD, Corporacion Sanitaria Parc Tauli; Study Director: Salvador Navarro-Soto, MD, PhD, Corporacion Sanitaria Parc Tauli; Study Director: Sandra Montmany-Vioque, MD, PhD, Corporacion Sanitaria Parc Tauli

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 26, 2019
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: May 7, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 11, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Trauma; Microcirculation; Resuscitation; Videomicroscopy; Thromboelastometry; Spectroscopy, Near-Infrared; Hypovolemic shock; B-Type Natriuretic Peptide
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Shock; Hypovolemia; Physiological Effects of Drugs; Natriuretic Agents; Natriuretic Peptide, Brain
• Other Study ID Numbers: CSPT-CG-PPT1