Back to resultsNorepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
Primary Purpose
Shock, Mechanical Ventilation
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Norepinephrine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Shock focused on measuring Shock, Respiration, artificial, Norepinephrine
Eligibility 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
Sites / Locations
- Hospital Geral
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Norepinephrine
Placebo
Arm Description
Outcomes
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.
Secondary Outcome Measures
To assess possible side effects related with the early norepinephrine infusion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00894621
Brief Title
Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
Official Title
Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Unidade de Terapia Intensiva
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Mechanical Ventilation
Keywords
Shock, Respiration, artificial, Norepinephrine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Norepinephrine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess possible side effects related with the early norepinephrine infusion.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Geral
City
Caxias do Sul
State/Province
Rio Grande do Sul
ZIP/Postal Code
95180000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
25004265
Citation
Piva J, Alquati T, Garcia PC, Fiori H, Einloft P, Bruno F. Norepinephrine infusion increases urine output in children under sedative and analgesic infusion. Rev Assoc Med Bras (1992). 2014 May-Jun;60(3):208-15. doi: 10.1590/1806-9282.60.03.008.
Results Reference
derived
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Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
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