Ecchymosis, Occlusion, Peripheral Venous Catheter Complications, Phlebitis
Conditions
Keywords
Peripheral venous catheter complications, PVC occlusion, PVC phlebitis
Brief summary
Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.
Interventions
OTHERheparin 100U/L flushes
peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* requiring i.v. therapy for an expected duration longer than five days * admitted to the 3rd medical ward of IRCCS Policlinico San Matteo
Exclusion criteria
* bleeding tendency * platelet count less than 100 x 109/L * coagulation defects * previous adverse reaction to heparin * programmed cytotoxic therapy * inability to give an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phlebitis or Occlusion | — | Phlebitis is defined as the presence of two or more symptoms/signs among pain, tenderness, warmth, erythema, swelling, or a palpable cord (score of ≥ 2 according to the Visual Infusion Phlebitis Score). Occlusion is defined as resistance to flushing as evidenced by the inability to administer 1 ml of flushing solution within 30 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ecchymosis | — | Ecchymosis is defined as a purple discoloration of the skin around the catheter insertion site larger than 1 cm. |
| Heparin induced thrombocytopenia | — | Heparin induced thrombocytopenia is defined as a fall in platelet count \> 50% of baseline value without any alternative explanation. To detect this phenomenon, platelet count is to be performed at baseline and, subsequently, every 5 days. |
Countries
Italy
Outcome results
None listed