Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Mechanical Ventilation Clinical Trial

Official title:

Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00894621
• Other study ID #: Noradrenalina precoce em UTIP
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 6, 2009
• Last updated: May 6, 2009
• Start date: November 2008

Study information

• Verified date: May 2009
• Source: Unidade de Terapia Intensiva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Shock

Intervention

Drug:
• Norepinephrine
Solution administration contend titrated norepinephrine in doses of 0,1 to 0,4 mc/kg/min. Initiated solution 24 hours after beginning mechanical ventilation. Use of the solution during 72 hours.
• Placebo

Locations

Country	Name	City	State
Brazil	Hospital Geral	Caxias do Sul	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Unidade de Terapia Intensiva

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 days	No
Secondary	To assess possible side effects related with the early norepinephrine infusion.		5 days	Yes