Evaluation of Resuscitation Markers in Trauma Patients

Trauma Clinical Trial

Official title:

Evaluation of Resuscitation Markers in Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772653
• Other study ID #: CSPT-CG-PPT1
• Status: Completed
• Start date: May 2016
• Est. completion date: March 26, 2019

Study information

• Verified date: May 2019
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypovolemia
• Hypovolemic Shock
• Shock
• Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Spain	Corporacion Sanitaria Parc Tauli	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Andrea Campos-Serra	Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital stay	Number of days that the patient remains in hospital	Through study completion, an average of 1-2 years
Other	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
Primary	Mortality	Death of the patient	Through study completion, an average of 1-2 years
Secondary	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
Secondary	Blood cell transfusion	Need for blood cell transfusion for patients	Through study completion, an average of 1-2 years
Secondary	Activation of the Massive blood transfusion protocol	Need for massive transfusion protocol activation on patients with suspicion of active bleeding	At hospital admission
Secondary	Surgical intervention for bleeding control	Need for surgical control on patients with active bleeding	Through study completion, an average of 1-2 years
Secondary	Arteriographic embolization for bleeding control	Need for arteriographic embolization on patients with active bleeding	Through study completion, an average of 1-2 years