N/A
Completed N=16
Pediatric Ethanol Lock Therapy Study.
Catheter-Related Infections
Source: ClinicalTrials.gov NCT00948441 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period. — 6.59; 25.90 number of CRBSI per 1000 catheter days — p=0.012
Summary
This study is a double-blind crossover design to compare prophylaxis with ethanol lock therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number of catheter related blood stream infections (CRBSI) in each time period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period. |
6.59; 25.90 | 0.012 sig |
| SECONDARY Safety, Side Effects |
11; 11 | — |
Eligibility Criteria
Inclusion criteria
- patients with central venous access and a history of three or more CRBSI in the prior 6 months
- age greater than 6 months
- anticipation for the need for continued central venous access over the next 7 months
- availability to come for a monthly study visit
- anticipation that the patient will receive medical care at Children's Hospital of Pittsburgh for the majority of the CRBSI which occur during the next 7 months and the ability to lock the central venous catheter for a minimum of 4 hours per day
Exclusion criteria
- age less than 6 months and greater than or equal to 21 years
- known immunodeficiency (with the exception of immunosuppression in a patient after organ transplantation)
- known allergy or intolerance to ethanol or heparin lock therapy
Data sourced from ClinicalTrials.gov (NCT00948441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.