Skip to content

Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00894621
Enrollment
40
Registered
2009-05-07
Start date
2008-11-30
Completion date
Unknown
Last updated
2009-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Shock

Keywords

Shock, Respiration, artificial, Norepinephrine

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.

Interventions

DRUGNorepinephrine

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.

DRUGPlacebo

Sponsors

Unidade de Terapia Intensiva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To assess possible side effects related with the early norepinephrine infusion.5 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026