Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies

Lymphoma Clinical Trial

Official title:

Multi-Center, Prospective, Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Safety and Effectiveness of an Antimicrobial Catheter Lock Solution in Maintaining Catheter Patency and Preventing Catheter Related Blood Stream Infections (CRBSI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01101412
• Other study ID #: 2009-0237
• Secondary ID: MDA-2009-0237CDR
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 9, 2010
• Last updated: February 13, 2013

Study information

• Verified date: February 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Antimicrobial solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium, and ethanol may help prevent blockages and infections from forming in patients with central venous access catheters or peripheral venous catheters.

PURPOSE: This randomized trial is studying an antimicrobial solution or saline solution in maintaining catheter patency and preventing catheter-related blood infections in patients with malignancies.

Description:

OBJECTIVES:

• To evaluate the safety of antimicrobial catheter lock solution comprising trimethoprim-sulfamethoxazole, edetate calcium disodium (EDTA), and ethanol versus saline solution in patients with malignancies.

• To compare the efficacy of this lock solution versus saline solution in maintaining catheter patency in these patients.

• To demonstrate the superiority of this lock solution in preventing or reducing the incidence of catheter-related bloodstream infections in patients with long-term indwelling catheters.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical site and randomized to 1 of 2 intervention arms.

• Arm I: Patients receive antimicrobial solution into the central or peripheral venous catheter (CVC or PVC) once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.

• Arm II: Patients receive saline solution into the CVC or PVC once daily for 90 days. Catheter dwell time is 1-24 hours. The catheter is then flushed through before any drug infusion or blood aspiration.

After completion of study, patients are followed up at 10 days.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of a malignancy

• Indwelling catheter (central or peripheral) with external lumen(s) that has been in place for = 7 days

• Inpatients must have each lumen of the catheter able to be locked with the study solution uninterruptedly for a minimum of one hour per day

• Outpatients must agree to flush and relock the catheter each day

PATIENT CHARACTERISTICS:

• Willing and able to follow the instructions required to complete the study

• No local or systemic infection as defined by the evidence of fever (e.g., body temperature = 38.0 degrees C) within 24 hours including any of the following:

• White Blood Count (WBC) = 12,000/mm³ or = 4,000/mm³ OR with a differential count showing = 10% bands

• Tachycardia defined as pulse rate = 100 bpm

• Tachypnea defined as respiratory rate > 20 breaths/minute

• Hypotension defined as systolic blood pressure (BP) = 90 mm Hg

• Signs and symptoms of localized catheter-related infection (e.g., tenderness and/or pain, erythema, swelling, or purulent exudate within 2 cm of entry site)

• No occluded (partially or totally) catheter defined as inability to either withdraw blood or instill 3 cc of fluid without resistance through any catheter lumen

• No known alcohol dehydrogenase deficiency

• No known history of allergic reaction to ethanol, trimethoprim (including trimethoprim/sulfamethoxazole), or any other components within the lock solution formulation

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No renal failure or creatinine level = 2.0 mg/dL

• No known heart failure or ejection fraction = 25%

• No alcohol dependency

PRIOR CONCURRENT THERAPY:

• Concurrent investigational chemotherapy agents allowed

• No concurrent non-chemotherapy investigational protocols

• Not requiring multiple central venous catheters

• Multiple lumens in a single catheter allowed

• No catheter coated or impregnated with heparin or antimicrobial or antiseptic agent

• No concurrent routine treatment of the underlying disease that will interfere with the lock solution

• No concurrent disulfiram or metronidazole

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Communicable Diseases
• Disease
• Infection
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• Edetate Calcium Disodium
Given through CVC or PVC.
• Ethanol
Given through CVC or PVC
• Trimethoprim-sulfamethoxazole
Given through CVC or PVC

Other:
• Hypertonic Saline
Given through CVC or PVC

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of occlusion as defined by the inability to infuse or withdraw 3 cc of saline from the catheter		60 days	No
Primary	Time to development of a catheter-related bloodstream infections during the period of lock therapy administration		60 days	No
Primary	Adverse events		60 days	Yes

External Links

•   University of Texas MD Anderson Cancer Center Official Website