Clinical trial · Interventional
Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies
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)
NCT01101412CI-TRIAL-00009462withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was not opened.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Infection | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Edetate Calcium Disodium | Drug | — | UNRESOLVED |
| Ethanol | Drug | — | UNRESOLVED |
| Hypertonic Saline | Other | — | UNRESOLVED |
| Trimethoprim-sulfamethoxazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Antimicrobial Solution
- description
- Antimicrobial solution into 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.
- interventionNames
- Drug: Edetate Calcium Disodium
- Drug: Ethanol
- Drug: Trimethoprim-sulfamethoxazole
- type
- ACTIVE_COMPARATOR
- label
- Arm II: Saline Solution
- description
- Saline solution into 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.
- interventionNames
- Other: Hypertonic Saline
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.