Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Baystate Medical Center. The registered enrollment target is 13 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680459
The ClinicalTrials.gov registry entry for NCT00680459 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 70% ethanol is the first listed.
NCT00680459 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.