Clinical Trial: Independent Predictors of Mortality in Polytrauma Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Independent Predictors of Mortality in Polytrauma Patients: a Prospective, Observational, Longitudinal Study

Brief Summary: Prospective observational trial searching for independent predictors of mortality. Data was collected at trauma scene, ER, three and 24 hours of hospital stay.The patients will be followed for 30 days after hospital admission.

Detailed Summary:

The study protocol was approved by the Institutional Medical Ethics Committee (CAPPesq 1081/09) and received financial support from the São Paulo State Research Foundation (Fundação de Amparo à Pesquisa do Estado de São Paulo - FAPESP) under no. 2010/03315-4.

At the end of data prospecting, 334 patients with severe trauma (Injury Severity Score, ISS, >15), assisted by the rescue system and taken to HCFMUSP-Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo- (by land and helicopter) were included in the study. This screening strategy included trauma patients with severe confirmed bleeding, patients with severe traumatic brain injury (TBI) and patients facing high-energy trauma (a marked characteristic of this trauma center). Patients under 18 years of age were excluded ( Figure 1).

In total, 78 patients were excluded because they did not fit the above criteria, leaving 256 patients for analysis. Of this total, 34 patients died before arriving at the emergency room, and 22 were removed from the analysis due to incomplete data, not signing the informed consent form or due to any situation in which the data collection could compromise victim care(care Figure(Figure 1).

All patients had data recorded at the following times: 1, at the trauma scene; 2, in the emergency room; 3, at 3 hours after hospital admission; and 4, at 24 hours after hospitalization.

Data regarding gender, age, trauma and trauma mechanism, medical procedures performed at all stages, time until arrival at the hospital and comorbidities were recorded. The clinical data collected were as follows: systolic blood pressure (SBP); diastolic blood pressure (DBP); heart rate (HR); respiratory rate (RR); art
Sponsor: University of Sao Paulo

Current Primary Outcome: Death [ Time Frame: Within the first 30 days ]

30 days after trauma mortality evaluation


Original Primary Outcome: Mortality [ Time Frame: Up to 3 years ]

30 days hospital stay mortality evaluation


Current Secondary Outcome:

Original Secondary Outcome: Severity of shock [ Time Frame: Up to 3 years ]

evaluation using blood lactate, use of vasoactive drugs


Information By: University of Sao Paulo

Dates:
Date Received: August 8, 2012
Date Started: October 2010
Date Completion:
Last Updated: January 8, 2015
Last Verified: January 2015