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

NCT02361840 | Unknown DMC

• 1 other identifier: HCFAA 003/12
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Troponin I; Pediatric shock

Outcome Measures

Primary Outcomes (1)

• Determination of results of Primary study cohort

  incidence of exposed , unexposed incidence , relative risk, attributable risk , absolute risk reduction

  2 years

Secondary Outcomes (1)

• Diagnostic Test

  2 months

Study Arms (2)

Exposed cohort: TI>0.05ng/ml

We call Exposed group to increased TI \> or = 0.05ng/ml We call Event to the onset of ARDS

No Exposed cohort: TI<0.05ng/ml

We cal no Exposed group to increased TI (\<0.05ng/ml) We call Event to the onset of ARDS

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The sample size Calculated sample size for study of prospective cohort with a confidence interval (CI) of 95%, 80% power. Exposed non-exposed 2:1 relation. Probability of occurring event in the cohort exposed 72% and 32% in the unexposed. We calculated that 41 patients of unexposed cohort and 21 of the exposed are required to observed differences. Total number of 62 patients (n=62). The sample size was calculated through the Epi Info version 7 of the Centers for Disease Control and Prevention (CDC), Atlanta. Population Population was taken from the room of emergency Pediatrics of the Hospital Civil Fray Antonio Alcalde (HCFAA).

You may qualify if:

• Informed consent signed by the parent to participate in the study.
• Children admitted to EUP the HCFAA of 1 month old 14 years showing shock with less than 24 hour evolution.
• Need for endotracheal intubation and mechanical ventilation.

You may not qualify if:

• Intake of toxic tricyclic antidepressants, cocaine and methamphetamines that increase value of TI per se.
• Transfusion three or more concentrated erythrocyte / plasma before entering UP.
• Pregnant girls
• Children with a previous diagnosis of uremic kidney injury

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Karla Isis Aviles Martinez

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Study Officials

• KARLA ISIS AVILES MARTINEZ, MD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

• MONICA CECILIA URIBE MERCADO, PhD., MD

  Universidad de Gudadalajara

  STUDY DIRECTOR

• IRAM ALBERTO VILLA MANZANO, PhD., MD

  University of Guadalajara

  STUDY DIRECTOR

Central Study Contacts

KARLA ISIS AVILES MARTINEZ, MD

CONTACT

0443331068136; draisispediatra@yahoo.com.mx

IRAM ALBERTO VILLA MANZANO, PhD., MD

CONTACT

0443331678093; albertovillamanzano@yahoo.com.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Karla Isis Aviles Martinez

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: February 12, 2015
• Study Start: October 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

ME (1)