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Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial (UP4061)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097031
Recruitment Status : Completed
First Posted : April 1, 2010
Last Update Posted : April 1, 2010
Sponsor:
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul

Tracking Information
First Submitted Date March 30, 2010
First Posted Date April 1, 2010
Last Update Posted Date April 1, 2010
Study Start Date October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 31, 2010)
blooding [ Time Frame: 72 hours ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial
Official Title Continuous or Intermittent for Keeping Arterial Catheter in Children: A Randomized Clinical Trial
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients with congenital heart disease
Condition Blood Pressure
Intervention Other: Infusion Intermittent
Study Groups/Cohorts
  • Continuous Infusion
  • Intermittent Infusion
  • Infusion Continuous
    Intervention: Other: Infusion Intermittent
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. English, Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 31, 2010)
140
Original Actual Enrollment Same as current
Actual Study Completion Date April 2009
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • patients in post-operative in congenital heart disease under 15 kg

Exclusion Criteria:

  • no consent of parents or responses
Sex/Gender
Sexes Eligible for Study: All
Ages up to 93 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01097031
Other Study ID Numbers UP4061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maria Carolina Witkowski, Instituto de Cardiologia do Rio Grande do Sul
Study Sponsor Instituto de Cardiologia do Rio Grande do Sul
Collaborators Not Provided
Investigators Not Provided
PRS Account Instituto de Cardiologia do Rio Grande do Sul
Verification Date March 2010