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Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Unidade de Terapia Intensiva.
Recruitment status was:  Active, not recruiting
Information provided by:
Unidade de Terapia Intensiva Identifier:
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
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.

Condition Intervention Phase
Shock Mechanical Ventilation Drug: Norepinephrine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

Resource links provided by NLM:

Further study details as provided by Unidade de Terapia Intensiva:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To assess possible side effects related with the early norepinephrine infusion. [ Time Frame: 5 days ]

Enrollment: 40
Study Start Date: November 2008
Arms Assigned Interventions
Experimental: Norepinephrine 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 Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00894621

Hospital Geral
Caxias do Sul, Rio Grande do Sul, Brazil, 95180000
Sponsors and Collaborators
Unidade de Terapia Intensiva
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00894621     History of Changes
Other Study ID Numbers: Noradrenalina precoce em UTIP
Study First Received: May 6, 2009
Last Updated: May 6, 2009

Keywords provided by Unidade de Terapia Intensiva:
Respiration, artificial

Additional relevant MeSH terms:
Vasoconstrictor Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents processed this record on September 21, 2017