Blood PressureUP4061NCT01097031
Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial
An observational study of Blood Pressure, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution for Keeping the mean invasive blood pressure whether the continuous system and the intermittent one. Read more about this study
- Who is it for?
- Ages Up to 93 months
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Infusion Intermittent
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Apr 2009
- Phase
- Observational
- 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 Up to 93 months
- All sexes
- No healthy volunteers
- Child
Study population: patients with congenital heart disease
Who may be able to join
- patients in post-operative in congenital heart disease under 15 kg
Who cannot join
- no consent of parents or responses
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90620-001
About this study
Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution for Keeping the mean invasive blood pressure whether the continuous system and the intermittent one.
- Conditions
- Blood Pressure
- Being tested
- Infusion Intermittent
- Keywords
- blood pressure, pediatric, nursing, maintenance arterial catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion IntermittentOther
| Study group | Role | What they receive |
|---|---|---|
| Continuous Infusion | Not described | |
| Intermittent Infusion | Not described | |
| Infusion Continuous | Not described Receives: Other: Infusion Intermittent |
What is being measured
The primary outcome is the main question the study is designed to answer.
blooding
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startOct 2007
- Study completionApr 2009
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 Blood PressureStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097031
- Sponsor's protocol ID
- UP4061
- Acronym
- UP4061
- Status last verified
- Mar 2010
- First submitted
- 30 Mar 2010
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Witkowski MC, Moraes MA, Firpo CM. Lack of difference between continuous versus intermittent heparin infusion on maintenance of intra-arterial catheter in postoperative pediatric surgery: a randomized controlled study. Rev Paul Pediatr. 2013 Dec;31(4):516-22. doi: 10.1590/S0103-05822013000400015.
PubMed 24473958
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01097031
- Acronym / sponsor ID
- UP4061 / UP4061
- Conditions
- Blood Pressure
- Keywords
- blood pressure, pediatric, nursing, maintenance arterial catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Apr 2010 (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.
Randomized Clinical Trial to evaluate which is the best infusion system of heparin solution for Keeping the mean invasive blood pressure whether the continuous system and the intermittent one.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Infusion | – | – |
| Intermittent Infusion | – | – |
| Infusion Continuous | – | Other: Infusion Intermittent |
Who may qualify
- Ages
- Up to 93 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with congenital heart disease
Key inclusion criteria (1 listed)
- patients in post-operative in congenital heart disease under 15 kg
Key exclusion criteria (1 listed)
- no consent of parents or responses
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 |
|---|---|---|
| Infusion Intermittent | Other | Infusion Continuous |
Primary outcome
blooding
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2010.
- Derived from this study: PubMed 24473958Witkowski MC, Moraes MA, Firpo CM. Lack of difference between continuous versus intermittent heparin infusion on maintenance of intra-arterial catheter in postoperative pediatric surgery: a randomized controlled study. Rev Paul Pediatr. 2013 Dec;31(4):516-22. doi: 10.1590/S0103-05822013000400015.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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?
An observational study of Blood Pressure, run by Instituto de Cardiologia do Rio Grande do Sul 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 1 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: finished, as of the sponsor's last update on 1 Apr 2010. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blooding (time frame: 72 hours). 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 NCT01097031, 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 1 Apr 2010.