Catheter Complications
Conditions
Keywords
Catheterization, Peripheral, Catheter Obstruction
Brief summary
Randomized, double-blind clinical trial to compare the efficacy of catheter sealing with saline, compared to low-dose heparin. 3,450 patients hospitalized at the Hospital Residencia Sant Camil, in Catalonia (Spain), will be randomized to each branch of study. The primary outcome will be the percentage of catheters removed due to obstruction in each branch of study. As secondary outcomes, the number of catheter-associated phlebitis, catheter-associated bacetrihemia, extravasation, and catheter loss will be measured. For the primary outcome, a superiority analysis will be carried out in terms of the percentage of obstructed catheters in each branch of the study.
Interventions
DRUGLow dose heparin
Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
DRUGNormal saline
Catheters will be sealed with 3mL of 0.9% sodium chloride
Sponsors
Consorci Sanitari de l'Alt Penedès i Garraf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 yo, admitted to the Hospital Residencia Sant Camil * Patients with at least one peripheral venous line for discontinuous treatment, which has not been channeled in a medical emergency situation. * Written informed consent
Exclusion criteria
* Allergy to heparin * Patients treated with unfractionated sodium heparin. * Patients in dialysis * Patients with a venous catheter indicated for diagnosis tests. * Patients with a venous catheter indicated for blood transfusion * Severe heparin-induced thrombocytopenia in recent months * Active uncontrollable bleeding during admission * Brain aneurysm or dissecting aorta, except in association with corrective surgery. * Confirmed / suspected cerebrovascular hemorrhage * Severe uncontrolled hypertension * Severe alterations in platelet coagulation \<30,000, TP\> 1.7 APTT ratio\> 1.7 ratio. * Patient included in another clinical trial with drugs or procedures that may affect the patency of venous catheters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of obstructed catheters | From date of randomization through the date of hospital discharge, an average of 10 days. | percentage of obstructed catheters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of catheter-associated phlebitis | From date of randomization through the date of hospital discharge, an average of 10 days. | Number of catheter-associated phlebitis |
| Number of catheter-associated bacterihemia episodes | From date of randomization through the date of hospital discharge, an average of 10 days. | Number of catheter-associated bacterihemia episodes |
| Number of catheter loss due to extravasation | From date of randomization through the date of hospital discharge, an average of 10 days. | Number of catheter loss due to extravasation |
Countries
Spain
Contacts
Primary ContactEsther Moreno Rubio
Backup ContactNoemí Casaponsa
Outcome results
None listed