Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Unidade de Terapia Intensiva.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Unidade de Terapia Intensiva
ClinicalTrials.gov Identifier:
NCT00894621
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess possible side effects related with the early norepinephrine infusion. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   1 Month to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894621

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

No publications provided by Unidade de Terapia Intensiva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00894621     History of Changes
Other Study ID Numbers: Noradrenalina precoce em UTIP
Study First Received: May 6, 2009
Last Updated: May 6, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Unidade de Terapia Intensiva:
Shock
Respiration, artificial
Norepinephrine

Additional relevant MeSH terms:
Norepinephrine
Vasoconstrictor Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014