NCT02772653

Evaluation of Resuscitation Markers in Trauma Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Andrea Campos-Serra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Trauma
• Hypovolemic Shock

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-03-26
• Completion: 2019-03-26
• First posted: 2016-05-13
• Last updated: 2019-05-14

Locations

1 site across 1 country: Spain