Condition 1: Central-line-associated bloodstream infection. Condition 2: Catheter-related thrombosis. Infection due to central venous catheter Other specified complications of cardiac and vascular prosthetic devices, implants and grafts
Conditions
Interventions
Intervention 1: Intervention Group: A lock solution containing 40% volume-volume Ethanol and 1000 units of Enoxaparin per cc (manufactured by Poish Daru Products Company) will be administered intralum
Sponsors
Tehran University of Medical Sciences
Pooyesh Darou Biopharmaceuticals company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age = 18 Hematologic malignancy or hematopoietic stem cell transplantation Recent insertion of the catheter (within the last 48 hours) in aseptic conditions of the operating room, and confirmation of its placement through radiography or radioscopy Informed consent from the patient or their legal guardian
Exclusion criteria
Exclusion criteria: History of any allergy/sensitivity/intolerance to Ethanol or Enoxaparin Pregnancy or breastfeeding History of alcohol abuse History of thrombocytopenia caused by heparin (HIT) or having an active hypocoagulable state Evidence of catheter site infection Evidence of active systemic infection (fever, chills, positive culture and leukocytosis) or documented bacteremia within 24 hours before catheter placement Receiving antibiotic treatment Patients in need of dialysis modalities Cirrhosis of the liver Having a history or documented active seizure disorder Patients whose catheters are placed in emergency situations Patients in critical conditions (those who need continuous infusion of fluid/medicine through both lumens)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of catheter-related bloodstream infection (CLABSI). Timepoint: From the beginning of the study until the time of catheter removal. Method of measurement: A positive catheter culture result is considered semiquantitative if there are more than 15 colony-forming units (cfu) per catheter segment or quantitative if there are more than 10^2 cfu per catheter segment when the organism reported from the catheter culture matches that of a peripheral blood culture. Additionally, it is considered positive if simultaneous quantitative blood cultures show a ratio of more than 3:1 cfu/ml (catheter versus peripheral blood), or if growth in a blood culture obtained through a hub catheter is detected by an automated blood culture system at least 2 hours earlier than a simultaneous peripheral blood culture of an equal volume.;Incidence rate of central venous catheter colonization. Timepoint: Once a week until the catheter is removed. Method of measurement: Swab culture from the inner surfaces of catheter hubs.;Safety and tolerance of ?Ethanol-Enoxaparin lock solution. Timepoint: Daily from the beginning to the end of the study. Method of measurement: Presenting Complaint and Physical Examination and Some laboratory tests such as liver enzyme tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of central venous catheter thrombosis. Timepoint: Daily, throughout the duration of the study. Method of measurement: Examining the catheter insertion site and, if clinically indicated, performing ultrasound.;The occurrence rate of catheter mechanical damage. Timepoint: Daily, throughout the duration of the study. Method of measurement: Catheter physical examination.;Rate of central venous catheter withdrawal due to infection, thrombosis, or mechanical damage. Timepoint: Daily, throughout the duration of the study. Method of measurement: Daily visit.;Duration of patient hospitalization. Timepoint: Daily, throughout the duration of the study. Method of measurement: Daily visit.;Mortality rate. Timepoint: Daily, throughout the duration of the study. Method of measurement: daily visit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Ahmad Arabzadeh
Ardabil University of Medical Sciences
Outcome results
None listed