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| Sponsor: | Institute of Child Health |
|---|---|
| Information provided by: | Institute of Child Health |
| ClinicalTrials.gov Identifier: | NCT01029717 |
Purpose
Most children admitted to paediatric intensive care units (PICU) need to have medicines given to them into their veins using a narrow tube, so they do not need repeated injections. This tube is called a central venous catheter. Occasionally these catheters can cause infections in the blood and sometimes the tubes can get blocked by small blood clots.
Some intensive care units already use antibiotic or heparin coated catheters, but there is no proof that these are better than the standard ones at preventing infections. Most of the PICU's in this country use standard lines. The only way to find out for certain is to compare children who are given antibiotic or heparin coated catheters with those who are given standard ones in a clinical trial. Because we do not know which type of catheter is best, the type of catheter each child receives in the study will be decided randomly by chance.
Each child in the trial will have the same chance of getting any of these three catheters:
The aim of this study is to see how the three types of catheters compare in reducing the amount of blood infections in children. We will also look at the costs involved. We hope to recruit 1200 children in the UK over 2 years. We hope that the information we get from this study will guide policy about purchasing impregnated Central Venous Catheters across the NHS and thereby improve treatment for children in the future.
| Condition | Intervention | Phase |
|---|---|---|
|
Catheter-Related Infections |
Device: Standard polyurethane Central Venous Catheter Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) Device: Heparin bonded polyurethane CVC |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomised Controlled Trial Comparing the Effectiveness of Heparin Bonded or Antibiotic Impregnated Central Venous Catheters (CVCs) With Standard CVCs for the Prevention of Hospital Acquired Blood Stream Infection in Children |
| Estimated Enrollment: | 1200 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Standard polyurethane Central Venous Catheter
Standard polyurethane Central Venous Catheter All CVCs used in the trial are CE marked medical devices used for their intended purpose. |
Device: Standard polyurethane Central Venous Catheter
Standard polyurethane Central Venous Catheter, All CVCs used in the trial are CE marked medical devices used for their intended purpose.
|
|
Active Comparator: Antibiotic impregnated polyurethane CVC
Antibiotic impregnated polyurethane CVC (minocycline and rifampicin) All CVCs used in the trial are CE marked medical devices used for their intended purpose. |
Device: Antibiotic impregnated polyurethane CVC (minocycline and rifampicin)
Antibiotic impregnated polyurethane CVC (minocycline and rifampicin. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
|
|
Active Comparator: Heparin bonded polyurethane CVC
Heparin bonded polyurethane CVC All CVCs used in the trial are CE marked medical devices used for their intended purpose. |
Device: Heparin bonded polyurethane CVC
Heparin bonded polyurethane CVC. All CVCs used in the trial are CE marked medical devices used for their intended purpose.
|
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Tracy Ball | +44 (0)20 74058207 |
| United Kingdom | |
| Institute of Child Health | Not yet recruiting |
| London, United Kingdom, WC1N 1EH | |
| Contact: TRACY BALL +44 (0)20 74058207 | |
| Principal Investigator: QUEN MOK, DR | |
| Study Director: | Ruth Gilbert, Professor | Institute of Child Health |
More Information
| Responsible Party: | RESEARCH AND DEVELOPMENT OFFICE, INSTITUTE OF CHILD HEALTH |
| ClinicalTrials.gov Identifier: | NCT01029717 History of Changes |
| Other Study ID Numbers: | 08EB20 |
| Study First Received: | December 9, 2009 |
| Last Updated: | December 9, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
Central Venous Catheters blood stream infection children, intensive care |
Heparin bonded antibiotic coated Children in Paediatric Intensive Care Unit |
|
Catheter-Related Infections Infection Anti-Bacterial Agents Minocycline Rifampin Calcium heparin Heparin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anticoagulants |
Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Antibiotics, Antitubercular Antitubercular Agents Enzyme Inhibitors Leprostatic Agents Nucleic Acid Synthesis Inhibitors |