ShockPhase 4NCT00894621
Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
A Phase 4 study testing Norepinephrine in people with Shock and Mechanical Ventilation, run by Unidade de Terapia Intensiva at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Shock, Mechanical Ventilation
- What is being tested?
- Norepinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Shock, Mechanical Ventilation
- Being tested
- Norepinephrine, Placebo
- Keywords
- Shock, Respiration, artificial, Norepinephrine
- Medical subject headings
- Shock, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Experimental | Not described Receives: Drug: Norepinephrine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (1)
To assess possible side effects related with the early norepinephrine infusion.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidade de Terapia Intensiva
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894621
- Sponsor's protocol ID
- Noradrenalina precoce em UTIP
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 7 May 2009
- Results posted
- No
Publications
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.
PubMed 25004265
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00894621
- Acronym / sponsor ID
- Noradrenalina precoce em UTIP
- Conditions
- Shock, Mechanical Ventilation
- Keywords
- Shock, Respiration, artificial, Norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Unidade de Terapia IntensivaUniversity, hospital or other
- Study start
- Nov 2008
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Experimental | Drug: Norepinephrine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineSolution 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. | Drug | Norepinephrine |
| Placebo | Drug | Placebo |
Primary outcome
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
1 secondary outcome
To assess possible side effects related with the early norepinephrine infusion.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
- Derived from this study: PubMed 25004265Piva 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine in people with Shock and Mechanical Ventilation, run by Unidade de Terapia Intensiva at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00894621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.