Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Shock Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Norepinephrine

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No