Evaluation of Resuscitation Markers in Trauma Patients

NCT ID: NCT02772653

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Hypovolemic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Blood Lactate

Intervention Type OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Blood Base Excess

Intervention Type OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Blood B-type Natriuretic Peptide

Intervention Type OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Blood Thromboelastometry (ROTEM)

Intervention Type OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Near-infrared spectroscopy

Intervention Type OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Sublingual videomicroscopy

Intervention Type OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood Lactate

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Intervention Type OTHER

Blood Base Excess

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Intervention Type OTHER

Blood B-type Natriuretic Peptide

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Intervention Type OTHER

Blood Thromboelastometry (ROTEM)

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Intervention Type OTHER

Near-infrared spectroscopy

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Intervention Type OTHER

Sublingual videomicroscopy

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Corporacion Parc Tauli

OTHER

Sponsor Role collaborator

Andrea Campos-Serra

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Campos-Serra

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrea Campos-Serra, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Sanitaria Parc Tauli

Salvador Navarro-Soto, MD, PhD

Role: STUDY_DIRECTOR

Corporacion Sanitaria Parc Tauli

Sandra Montmany-Vioque, MD, PhD

Role: STUDY_DIRECTOR

Corporacion Sanitaria Parc Tauli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36053289 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSPT-CG-PPT1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.