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Evaluation of Potassium as a Mortality Predictor (STARS)

This study is currently recruiting participants.
Verified August 2012 by University of Sao Paulo
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luiz Guilherme Villares da Costa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01669577
First received: August 8, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

Prospective observational trial testing the behavior of potassium at trauma scene, ER, three and 24 hours of hospital stay.The patients will be followed for 30 days after hospital admission.


Condition Intervention
Secondary or Recurrent Hemorrhage as Early Complication of Trauma
 Procedure: analysis of blood samples (0,2 ml)
Procedure: analysis of blood samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Potassium as a Marker of Tissue Hypoxia in Prehospital Setting in Trauma Patients and Its Correlation With Severity of Injury, Shock, Coagulopathy and Mortality

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Mortality [ Time Frame: Within the first 30 days ] [ Designated as safety issue: Yes ]
    30 days hospital stay mortality evaluation


Secondary Outcome Measures:
  • Severity of shock [ Time Frame: Prehospital setting, ER admission,3 and 24 of hospital stay ] [ Designated as safety issue: Yes ]
    Venous blood gases, lactate, hemoglobin,hematocrit,eletrolytes,glucose


Other Outcome Measures:
  • coagulopathy [ Time Frame: Prehospital setting, ER admission,3 and 24 hours of hospital stay ] [ Designated as safety issue: Yes ]
    Use of PT/INR at trauma scene, ER, 3 and 24 hs of hospital stay


Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
severe trauma patients
intervention : analysis of blood samples
 Procedure: analysis of blood samples (0,2 ml)
analysis of blood samples (0,2 ml)
Procedure: analysis of blood samples
analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Severe trauma patients evaluated at trauma scene

Criteria

Inclusion Criteria:

  • severe trauma

Exclusion Criteria:

  • under 18 years old patient,
  • technical problems during rescue maneuvers,
  • impossibility of blood sample draw during rescue
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669577

Contacts
Contact: Luiz G Costa, MD 11 985584737 Lgvc76@yahoo.com.br
Contact: Luiz M Malbouisson, PhD 11 981114141 Malbouisson@gmail.com

Locations
Brazil
Instituto Central do Hospital das Clínicas da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403000
Contact: Luiz Guilherme Costa, MD     55 11 985584737     lgvc76@yahoo.com.br    
Contact: Luiz Marcelo Malbouisson, PhD     55 11 981114141     malbouisson@gmail.com    
Principal Investigator: Luiz Guilherme Costa, MD            
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Luiz G Costa, MD Hospital das Clínicas da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: Luiz Guilherme Villares da Costa, Anesthesia division clinical staff physician, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01669577     History of Changes
Other Study ID Numbers: STARS.
Study First Received: August 8, 2012
Last Updated: August 21, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
potassium
trauma
mortality

Additional relevant MeSH terms:
Hemorrhage
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013