NCT00894621

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
Last Updated

May 7, 2009

Status Verified

May 1, 2009

First QC Date

May 6, 2009

Last Update Submit

May 6, 2009

Conditions

ShockMechanical Ventilation

Keywords

ShockRespiration, artificialNorepinephrine

Outcome Measures

Primary Outcomes (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.

    5 days

Secondary Outcomes (1)

  • To assess possible side effects related with the early norepinephrine infusion.

    5 days

Study Arms (2)

Norepinephrine

EXPERIMENTAL
Drug: Norepinephrine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NorepinephrineDRUG

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.

Norepinephrine
PlaceboDRUG
Placebo

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Geral

Caxias do Sul, Rio Grande do Sul, 95180000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 25004265DERIVED

MeSH Terms

Conditions

ShockRespiratory Aspiration

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 7, 2009

Study Start

November 1, 2008

Last Updated

May 7, 2009

Record last verified: 2009-05

Locations

BR(1)