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NCT00680459 · ClinicalTrials.gov registry record · Phase 3
Ethanol Locks for the Treatment of Central Venous Line Infections
A Phase 3 study, sponsored by Baystate Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
NCT00680459: Clinical Trial Phase 3 study, sponsored by Baystate Medical Center.
NCT00680459 is a Phase 3 study that was terminated before completion, run by Baystate Medical Center. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00680459, a Phase 3 study, was terminated before completion, sponsored by Baystate Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
Study Summary
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections Study Design Randomized Controlled Trial Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution. Outcome Measures Treatment success as defined by- * Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment) * Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections Treatment failure as defined by- * Clinical worsening during treatment * Removal of the line due to persistent infection or sepsis * Recurrence of infection with the same pathogen within 30 days
Interventions
- DRUG 70% ethanol
- DRUG heparin flush solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
Why NCT00680459 stopped before completion
NCT00680459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which 70% ethanol is the first listed.
NCT00680459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00680459 about?
NCT00680459 is a clinical study titled "Ethanol Locks for the Treatment of Central Venous Line Infections". Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections Study Design Randomized Controlled Trial Study Protocol Only those...
What is the current status of trial NCT00680459?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2008-05. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00680459?
The interventions under investigation include: 70% ethanol (DRUG), heparin flush solution (DRUG).
Who is sponsoring clinical trial NCT00680459?
This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00680459's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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