Investigating the preventive effect of gentamicin-lock and ethanol-lock in central venous catheter infection in children admitted to the pediatric intensive care unit.

Investigating the effect of lock therapy in reducing central venous catheter infection in patients admitted to the pediatric special care unit

Clinical trial with control group, with parallel groups, single-blind, randomized, phase 2 on 228 patients. Randomaize.com was used for randomization.

Patients are divided into three groups and in an interventional way, in one group ethanol, in one group gentamicin to smear the catheter path as lock therapy and in the third group, as a control group, no drug is used to smear the catheter path. Gentamicin with a volume of 0.25 cc (10 mg) is mixed with 9.75 cc of normal saline (ideally 1 mg in 1 cc) with a total volume of 10 cc. We inject the contents of the syringe of 5 cc of normal saline into the lumen and then aspirate. After the blood returns, the amount aspirated in the syringe is equivalent to the volume required to seal the lumen. Lock therapy is performed once a day in each line and continues for 7 days. In the case of ethanol, 70% alcohol is used. The volume of 0.2 cc is used to fill the lumen and remains in each lumen of the catheter for 4 hours, and during this time, the lumen must be unused. Before and after each lock therapy with ethanol, the line is washed with 5 to 10 cc of normal saline. Lock therapy is performed once a day in each line and continues for 7 days.

- Children between the ages of 1 month and 18 years admitted to the pediatric intensive care unit - Children who undergo central venous catheter implantation.

Group 1: patients receiving ethanol as lock therapy. Group 2: patients receiving gentamicin as lock therapy.

Prevention of infection (blood culture)

Individual simple randomization Random number table randomization tool using www.randomization.com Allocation Concealment method: envelopes closed. In this method, first, a random sequence is created, then based on the size of the research sample, a number of envelopes with aluminum wrappers (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the generated random sequences is recorded on a card, and the cards are inside The letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

For blinding, statistical consultants and data analysts were unaware of the patient's randomization and placement in the therapy group.

Part of the data related to the main outcomes

Six months after the results are published

Academic institutions

For the purpose of research for the academic community

Dr. Gholamreza Khademi khademigh@mums.ac.ir

The request will be sent via email to Dr. Gholamreza Khademi and correspondence will be sent about two weeks after the registration of the data request.