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IRCT20221129056657N3 IRCT 2023-11-14 Mashhad University of Medical Sciences Investigating the preventive effect of ethanol and gentamicin in central venous catheter infection Investigating the preventive effect of gentamicin-lock and ethanol-lock in central venous catheter infection in children admitted to the pediatric intensive care unit. 2023-11-21 anticipated 228 Complete https://irct.ir/trial/73284 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: For blinding, statistical consultants and data analysts were unaware of the patient's randomization and placement in the therapy group. 2 Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts. Intervention 1: Intervention group: 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. Then that lumen is not used for 4 hours. Then the above volume is thrown away and varnish therapy is immediately performed in the other lumen. Two-lumen and three-lumen catheters will be used depending on the age and condition of the patient, and each lumen will be subjected to lock therapy separately and respectively. Lock therapy is performed once a day in each line and continues for 7 days. Intervention 2: Intervention group: 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. Two-lumen and three-lumen catheters are used depending on the age and condition of the patient. and each lumen will be subjected to lock therapy separately and in order. 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. From the time of catheter insertion, lock therapy starts and continues as prophylaxis, and the final result is evaluated after 7 days. Intervention 3: Control group: As a control group, no drug is used to impregnate the catheter path. Yes - There is a plan to make this available What will be shared: Part of the data related to the main outcomes When: Six months after the results are published To whom: Academic institutions Conditions: For the purpose of research for the academic community Where to obtain: Dr. Gholamreza Khademi khademigh@mums.ac.ir How to obtain: 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. Comments:
public Gholamreza Khademi
Akbar Children's Hospital-Shahid Kaveh Boulevard - Mashhad
Mashhad Iran (Islamic Republic of) ٩١٧٧٨٩٧١۵٧ +98 51 3189 1780 khademigh@mums.ac.ir Mashhad University of Medical Sciences scientific Gholamreza Khademi
Akbar Hospital, Shahid Kaveh Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 khademigh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children between the ages of 1 month and 18 years admitted to the pediatric intensive care unit Children undergoing central venous catheter implantation 1 month 18 years Both Hypersensitivity reaction to antibiotics or ethanol that is injected into the line. Any dysfunction of the line occurs after drug injection T82.7 Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts Prevention Prevention N/A Intervention group: 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. Then that lumen is not used for 4 hours. Then the above volume is thrown away and varnish therapy is immediately performed in the other lumen. Two-lumen and three-lumen catheters will be used depending on the age and condition of the patient, and each lumen will be subjected to lock therapy separately and respectively. Lock therapy is performed once a day in each line and continues for 7 days. Intervention group: 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. Two-lumen and three-lumen catheters are used depending on the age and condition of the patient. and each lumen will be subjected to lock therapy separately and in order. 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. From the time of catheter insertion, lock therapy starts and continues as prophylaxis, and the final result is evaluated after 7 days. Control group: As a control group, no drug is used to impregnate the catheter path. Prevention of infection (blood culture). Timepoint: Seven days after the start of the intervention. Method of measurement: Bactec automatic blood culture machine. Duration of stay in PICU. Timepoint: The time of discharge of the patient from the intensive care unit. Method of measurement: Use of checklists and patient records. Mashhad University of Medical Sciences Approved 2023-09-23 Committee on Ethics in Research, Faculty of Medicine, Mashhad University of Medical Sciences Qurashi Building، Daneshgah Street,Mashhad. Mashhad Razavi Khorasan Iran (Islamic Republic of)