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Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Information source: Unidade de Terapia Intensiva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Shock; Mechanical Ventilation

Intervention: Norepinephrine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Unidade de Terapia Intensiva

Summary

The purpose of this study is to assess the effectiveness from early infusion of norepinephrine in pediatric patients submitted to mechanical ventilation for the use of sedative and analgesics drugs.

Clinical Details

Official title: Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To compare norepinephrine and placebo as initial therapy in pediatric patients submitted to the mechanical ventilation with reference to hemodynamic parameters, diuresis and diuretics' use.

Secondary outcome: To assess possible side effects related with the early norepinephrine infusion.

Eligibility

Minimum age: 1 Month. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children, who, in the arrival or during the admission in pediatric intensive care

unit, develop the need for mechanical ventilation and continuous infusion of sedatives and/or analgesics Exclusion Criteria:

- Patients after cardiac arrest

- Patients with tracheostomy

- Patients with renal and/or hepatic failure

- Patients with previous episode of cardiac arrythmia

- Patients with mechanical ventilation forecast lesser that four days

Locations and Contacts

Hospital Geral, Caxias do Sul, Rio Grande do Sul 95180000, Brazil
Additional Information

Starting date: November 2008
Last updated: May 6, 2009

Page last updated: August 23, 2015

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