Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894621
Recruitment Status : Unknown
Verified May 2009 by Unidade de Terapia Intensiva.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2009
Last Update Posted : May 7, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Shock Mechanical Ventilation Drug: Norepinephrine Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. To assess possible side effects related with the early norepinephrine infusion. [ Time Frame: 5 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894621

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00894621     History of Changes
Other Study ID Numbers: Noradrenalina precoce em UTIP
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 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