This trial is active, not recruiting.

Conditions shock, mechanical ventilation
Treatments norepinephrine, placebo
Phase phase 4
Sponsor Unidade de Terapia Intensiva
Start date November 2008
Trial size 40 participants
Trial identifier NCT00894621, Noradrenalina precoce em UTIP


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
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 Comparator)

Primary Outcomes

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.
time frame: 5 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 1 month up to 12 years old.

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

Additional Information

Official title Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Unidade de Terapia Intensiva.