Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698214
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
A systolic blood pressure (SBP) lower than the heart rate (HR) could indicate a poor condition in trauma patients. In such scenarios, the reversed shock index (RSI) is <1, as calculated by the SBP divided by the HR. This study aimed to clarify whether RSI could be used to identify high-risk adult patients with isolated traumatic brain injury (TBI).

Condition or disease Intervention/treatment
Traumatic Brain Injury Other: reversed shock index < 1 Other: reversed shock index ≥ 1

Layout table for study information
Study Type : Observational
Actual Enrollment : 1216 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Is There a Worse Outcome When the Systolic Blood Pressure is Lower Than Heart Rate in Those Adult Trauma Patients With Isolated Head/Neck Injury
Actual Study Start Date : March 23, 2016
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : February 22, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
isolated traumatic brain injury
Adult patients having isolated traumatic brain injury with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included. The patients were grouped and analyzed according to reversed shock index < 1 or reversed shock index ≥ 1.
Other: reversed shock index < 1
Among patients with isolated TBI, those with an RSI < 1 had higher mortality

Other: reversed shock index ≥ 1
Among patients with isolated TBI, those with an RSI ≥ 1 had lower mortality




Primary Outcome Measures :
  1. in-hospital mortality [ Time Frame: up to 5 months ]
    To measure the outcome of patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included. We excluded patients younger than 18 or older than 65 years of age. Patients were grouped and analyzed according to RSI (< 1 or ≥ 1).
Criteria

Inclusion Criteria:

  • Adult patients having isolated TBI with a head abbreviated injury scale (AIS) ≥ 3 and without severe injury to other regions (other AIS ≤ 1) were included

Exclusion Criteria:

  • Patients with incomplete registered data were also excluded

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03698214     History of Changes
Other Study ID Numbers: CGRPG8F0011
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
systolic blood pressure
reversed shock index
traumatic brain injury
mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Neck Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System