| Trial ID: | L0327 |
| Source ID: | NCT02618317
|
| Associated Drug: |
Heparin Lock Solution
|
| Title: |
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
|
| Acronym: |
CLOCK
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Heparin Lock Solution|DRUG: Trissodium Citrate 30%|DRUG: Minocycline-EDTA 30 mg/ml - 3 mg/ml
|
| Outcome Measures: |
Primary: Poor Blood Flow Rate(BFR), Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial, 100 days | Secondary: Adverse Drug Reactions Related to lock solutions (ADR), ADR is considered secondary endpoint for this trial, 100 days|Cather-Related Blood Stream Infection (CRBSI), CRBSI is considered secondary endpoint for this trials, 100 days
|
| Sponsor/Collaborators: |
Sponsor: University of Sao Paulo | Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
75
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2013-07
|
| Completion Date: |
2016-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-12-02
|
| Locations: |
Integrated Centre of Nephrology, Guarulhos, Sao Paulo, 07013-142, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT02618317
|
