Heparinization vs Salinization of the Peripheral Venous Catheter
ConditionCatheter Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorConsorci Sanitari de l'Alt Penedès i Garraf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Allergy to heparin
Patients treated with unfractionated sodium heparin.
Patients in dialysis
Patients with a venous catheter indicated for diagnosis tests.
Trial design
Design model
Parallel
Treatments tested in this trial
Low dose heparin
DrugCatheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL)
Normal saline
DrugCatheters will be sealed with 3mL of 0.9% sodium chloride
Treatment groups
3,450 Participants
are divided into 2 treatment groupsGroup A: Catheter sealing with low dose heparinExperimental treatment 1 intervention
Group B: Catheter sealing with normal salineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of obstructed catheters
percentage of obstructed catheters
Time frame
From date of randomization through the date of hospital discharge, an average of 10 days.Secondary outcomes
1
Number of catheter-associated phlebitis
Number of catheter-associated phlebitis
Time frame
From date of randomization through the date of hospital discharge, an average of 10 days.2
Number of catheter-associated bacterihemia episodes
Number of catheter-associated bacterihemia episodes
Time frame
From date of randomization through the date of hospital discharge, an average of 10 days.3
Number of catheter loss due to extravasation
Number of catheter loss due to extravasation
Time frame
From date of randomization through the date of hospital discharge, an average of 10 days.Sponsors and contacts
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Source ClinicalTrials.gov