Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population

Table 1 Participant timeline

Procedure	Pre-lock	First lock	During locking period	During ICU/HAU stay
Informed consent	x^a
Inclusion/exclusion criteria	x^b
Demographics	x
Medical history	x
Consent to receive blood products	x^c
Pregnancy test	x^d
Prior/concomitant medication	x^e
Central line placement (as per SOC)	x
Central line flushing (q12 as per SOC)^f		x	x
Central line aspiration^g		x	x
Study medication (in the experimental group)		x	x
Standard of care (in the control group)		x	x
Adverse events		x	x
Data collection	x^h	x^h	x^h	xⁱ

^aInformed consent will be collected in a waived fashion
^bConfirmation of the eligibility will occur at the baseline visit to make sure that the person still remains eligible
^cThe patient must provide consent to receive blood products before moving forward
^dPregnancy test, if completed, would need to be negative before going forward
^eAs other medications may have an unforeseen impact on 4% tetrasodium EDTA, these medications are being tracked to determine if this is the case
^fStandard of care—the central line is periodically flushed with normal saline or citrate (for hemodialysis catheters) to ensure patency
^gStandard of care—the central line lock is aspirated of any solution that may remain in the lock between locking or medication administration
^hData collection, if applicable, will occur during the defined periods when patients are hospitalized in the ICU/HAU. This data will be collected in order to determine primary and secondary outcomes
ⁱData collection in the form of checking of medical imaging reports will continue for the duration of the patients’ ICU/HAU stay, even if the patient no longer has a central line

ISSN: 1745-6215