Occlusion Clinical Trial
Official title:
Citrate 4% Versus Heparinised Saline in Preventing Peripherally Inserted Central Catheter (PICC) Occlusions
This study is a prospective, randomized, non-blinded study. 1 group will be assigned the standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This is consistent with the standard procedure of PICC care in the investigators' centre. The second group will be assigned the intervention with use of 4% citrate lock (Dirinco Citra-Lock 4%) in between each catheter use.
PICC occlusion in patients requiring long-term central line access for chemotherapy is a
recurrent issue. Occlusion is usually managed by administration of fibrinolytic agents, and
subsequent removal and re-insertion if unsuccessful.
Locally, the current clinical practice is to use heparinised saline at a concentration of
10U/ml as a locking agent in between use of the PICC line to prevent occlusion. Citrate 4%
has antithrombotic and antibacterial properties, which makes it potentially superior to
heparin as a locking agent. Citrate chelates ionised calcium in blood, inhibiting
calcium-dependent clotting pathways. Also, as a chelating agent, it results in inhibition of
growth of micro-organisms. Citrate-based anticoagulation is often preferred over heparin
because of its safety and rapid systemic clearance. Citrate also is safe for heparin induced
thrombocytopenia patients.
The effects of each agent have been compared in renal patients with central lines on
haemodialysis. These studies have demonstrated that 4% citrate is at least equivalent
(MacRae, 2008) or even superior (Grudzinski, 2007) to heparin 5000U/ml in preventing
catheter occlusions, and superior in preventing infection (Weijmer, 2002).
This study is a prospective, randomized, non-blinded study. 1 group will be assigned the
standard arm with use of heparinised saline (10U/ml) lock in between each catheter use. This
is consistent with the standard procedure of PICC care in the investigators' centre. The
second group will be assigned the intervention with use of 4% citrate lock (Dirinco
Citra-Lock 4%) in between each catheter use.
Patients will be followed for up to 6 months or until the catheter is removed, or until the
study ends. A standardised data tracking form will be used to assess baseline
characteristics as well as number of times urokinase was used. Nursing documentation
regarding each PICC flushing (standard documentation as per hospital protocol) will be
evaluated for number of discrete attempts made to troubleshoot lines without use of
urokinase. Positive blood culture results will be recorded for each patient.
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