Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection
Study Details
Study Description
Brief Summary
RATIONALE: Heparin or M-EDTA may prevent catheter-related infections and blockages in patients at high risk for a catheter-related infection. It is not yet known whether heparin is more effective than M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.
PURPOSE: This randomized clinical trial is studying heparin to see how well it works compared with M-EDTA in preventing catheter-related infections and blockages in patients at high risk for a catheter-related infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
OBJECTIVES:
Primary
- Compare the incidence of catheter-related infections (Staphylococcal and Candida) in patients at high risk for a catheter-related infection treated with heparin vs minocycline hydrochloride and edetate calcium disodium (M-EDTA).
Secondary
- Compare the incidence of catheter occlusions in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, prospective, multicenter study. Patients are stratified according to type of catheter (tunneled central venous catheter [CVC] vs nontunneled percutaneous CVC) and participating center. Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA) flush solution into the CVC once daily.
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Arm II: Patients receive heparin flush solution into the CVC once daily. Treatment in both arms continues for up to 3 months in the absence of unacceptable toxicity or until the removal of the catheter.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily. |
Drug: Minocycline-EDTA
M-EDTA flush solution into CVC once daily.
Other Names:
|
| Experimental: Arm II Heparin flush solution into CVC once daily. |
Drug: Heparin
Heparin flush solution into CVC once daily.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of catheter-related infections during the study period (3 months) [3 months]
Secondary Outcome Measures
- Incidence of catheter occlusions during periods of prophylaxis (e.g., time period in which the catheter is locked with heparin or minocycline hydrochloride and edetate calcium disodium [M-EDTA]) [3 months]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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At high risk of acquiring a catheter infection, as evidenced by any of the following:
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Diagnosis of leukemia, lymphoma, myeloma, or melanoma-sarcoma
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Undergoing hematopoietic stem cell transplantation
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Receiving aldesleukin
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Pediatric cancer patients
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New (≤ 10 days old) functioning externalized tunneled or nontunneled central venous catheter (CVC), such as a Hickman/Broviac or Hohn catheter, or peripherally inserted central venous catheter (PICC) utilized for infusion of chemotherapy, blood and blood products, or other intermittent infusions
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No occluded CVC
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No existing local or systemic catheter infection
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More than 3 days since removal of a prior CVC due to an infection
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No externalized CVC that is projected to remain in place for < 2 weeks
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No infusion ports or Groshong catheters
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No coated CVC impregnated with an antimicrobial or antiseptic agent
PATIENT CHARACTERISTICS:
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Life expectancy ≥ 3 months
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No history of allergy to any tetracycline
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No contraindication to flush solution dwell time of ≥ 4 hours
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No hypocalcemia while receiving calcium supplementation through the catheter
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Not pregnant or nursing
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jorge Cortes, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ID93-004
- P30CA016672
- MDA-ID-93004
- CDR0000500199