Heparin or M-EDTA in Preventing Catheter-Related Infections and Blockages in Patients at High Risk for a Catheter-Related Infection

NCT ID: NCT00378781

Last Updated: 2012-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

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.

• Arm I: Patients receive minocycline hydrochloride and edetate calcium disodium (M-EDTA) flush solution into the CVC once daily.
• 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Arm I

Minocycline hydrochloride + Edetate Calcium Disodium (M-EDTA) flush solution into CVC once daily.

Group Type: EXPERIMENTAL

Minocycline-EDTA

Intervention Type: DRUG

M-EDTA flush solution into CVC once daily.

Arm II

Heparin flush solution into CVC once daily.

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Heparin flush solution into CVC once daily.

Interventions

Heparin

Heparin flush solution into CVC once daily.

Intervention Type: DRUG

Minocycline-EDTA

M-EDTA flush solution into CVC once daily.

Intervention Type: DRUG

Other Intervention Names

Hep-Lock; Minocycline hydrochloride; Edetate Calcium Disodium; M-EDTA

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• At high risk of acquiring a catheter infection, as evidenced by any of the following:

• Diagnosis of leukemia, lymphoma, myeloma, or melanoma-sarcoma
• Undergoing hematopoietic stem cell transplantation
• Receiving aldesleukin
• Pediatric cancer patients
• 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

• No occluded CVC
• No existing local or systemic catheter infection

• More than 3 days since removal of a prior CVC due to an infection
• No externalized CVC that is projected to remain in place for < 2 weeks
• No infusion ports or Groshong catheters
• No coated CVC impregnated with an antimicrobial or antiseptic agent

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months
• No history of allergy to any tetracycline
• No contraindication to flush solution dwell time of ≥ 4 hours
• No hypocalcemia while receiving calcium supplementation through the catheter
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Cortes, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Related Links

http://www.mdanderson.org

UT MD Anderson Cancer Center Website

Other Identifiers

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MDA-ID-93004

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000500199

Identifier Type: REGISTRY

Identifier Source: secondary_id

ID93-004

Identifier Type: -

Identifier Source: org_study_id