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Predictive Value of Troponin I for Acute Respiratory Distress Syndrome in Children With Shock

NCT02361840 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2015-02-12

No results posted yet for this study

Summary

Shock is one of the five leading causes of income and mortality in emergencies. It generates a decrease in the availability of oxygen to the tissues, resulting in ischemia, pulmonary involvement and tissue reperfusion syndrome. This pathologies can trigger Syndrome of Acute Respiratory Distress (ARDS) and death.

Troponin I (TI) has been reported as early marker for ischemia and mortality other than coronary syndromes in critical patients.

Objective. Set the increase of TI as a predictor of ARDS in children with shock.

Null hypothesis. Increase serum in children with shock predicts the onset of ARDS.

Methodology. Prospective cohort type test diagnostic. Displays institutional. Sampling non-probability, consecutive inclusion. Calculation of the sample size: interval of confidence (IC) 95%, power - 80%; ratio non-exposed: exposed 2:1; n = 62.

Inclusion criteria: informed consent signed by the parent; children admitted to pediatric emergency (PEU) 1 month to 14 years with shock requiring mechanical ventilation.

Exclusion criteria: intake of toxic (TI value increment per will), ≥3 concentrated erythrocyte transfusion or plasma prior to entering PEU.

The investigators call exposure to the increase of TI≥0 05ng/ml and event to the development of ARDS. Determine TI value in plasma serum in the first 24 h, through Enzyme Immunoassay for the Quantitative Determination of Cardiac-Specific Troponin-I in Human Serum (cTnI ELISA), (reported as cardiac triage). Monitoring for 7 days.

Study was approved by Hospital Ethics Committee (Research record 003/12)

Conditions

  • ARDS

Sponsors & Collaborators

  • Hospital Civil de Guadalajara

    lead OTHER

Principal Investigators

  • KARLA ISIS AVILES MARTINEZ, MD · University of Guadalajara

  • MONICA CECILIA URIBE MERCADO, PhD., MD · Universidad de Gudadalajara

  • IRAM ALBERTO VILLA MANZANO, PhD., MD · University of Guadalajara

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361840 on ClinicalTrials.gov