Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Phase 4

• Conditions: Shock; Mechanical Ventilation
• Interventions: Drug: Placebo; Drug: Norepinephrine

• Registration Number: NCT00894621
• Lead Sponsor: Unidade de Terapia Intensiva

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Status Verified: 2009-05
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-06
• Last Update Submitted: 2009-05-06
• Study First Posted: 2009-05-07
• Last Update Posted: 2009-05-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Norepinephrine	Norepinephrine	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To assess possible side effects related with the early norepinephrine infusion.	5 days

Trial Locations

Locations (1)

Hospital Geral; 🇧🇷 Caxias do Sul, Rio Grande do Sul, Brazil