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IRCT20210307050610N1 IRCT 2021-05-11 Sabzevar University of Medical Sciences Evaluation of serum replacement frequency used in drug infusion on serum contamination and incidence of phlebitis ندارد Investigation the effect of the 24 and 48-hour changing in chloride sodium 0.9% used in infusion of drug on the amount of phlebitis and serum infection 2021-05-22 anticipated 300 Complete https://irct.ir/trial/54842 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: not, Randomization description: By simple random sampling method of people referring to Hashemi Rafsanjani Hospital in Shirvan who are eligible after sample selection is divided into two experimental groups (with 48-hour change of 0.9% sodium chloride serum) and the control group (with normal 24-hour change) be. In this study, individuals were assigned to two groups using permutation block method. In this method, A represents the individual receiving the intervention and B represents the individual in the control group. Considering the quadruple block; Instead of AABB code 0, give ABAB code 1, ABBA code 2, BAAB code 3, BBAA code 4 and BABA code 5. Then, using a table of random numbers, he randomly selected the starting point. Considering the order of the numbers in the table, we place the permutation corresponding to each number we encounter. So finally, by selecting the numbers from the table, how to assign a total of 300 people to the two groups will be determined, Blinding description: The data analyzer does not know which group the people are in. Laboratory samples are given to the laboratory expert anonymously based on numbers and he does not know if the samples are in the intervention or control group. 3 Condition 1: Phlebitis. Condition 2: Catheter-related infection. Intervention 1: Intervention group: The serum used in the infusion of drugs will be changed every 48 hours. At the end of 48 hours from the start of serum infusion, 5 cc of each serum was drawn with a syringe and sterile method and sent to the laboratory under sterile conditions and in the shortest possible time and each sample was cultured by a blind laboratory expert. Then count the number of colonies that appear and if more than fifteen microbial growths are seen in each container, the result of positive culture and the corresponding serum will be considered infected. If the number of colonies was less than or equal to 15 and the person was asymptomatic, serum is considered colonization. Intervention 2: Control group: The serum control group used in the infusion of drugs will be changed every 24 hours. At the end of 48 hours from the start of serum infusion, 5 cc of each serum was drawn with a syringe and sterile method and sent to the laboratory under sterile conditions and in the shortest possible time and each sample was cultured by a blind laboratory expert. Then count the number of colonies that appear and if more than fifteen microbial growths are seen in each container, the result of positive culture and the corresponding serum will be considered infected. If the number of colonies was less than or equal to 15 and the person was asymptomatic, serum is considered colonization. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "No more information"
public Hasan Khalili
Campus of University of Medical Sciences,Nuclear Martyrs Blvd
Sabzvar Iran (Islamic Republic of) 9617913112 +98 51 4408 6458 khaalili894@gmail.com Sabzevar University of Medical Sciences scientific Hasan Khalili
Vice Chancellor for Education, University, Tohid Shahr Blvd
sabzvar Iran (Islamic Republic of) 9613873136 +98 51 4401 1300 khalili894@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) People over the age of 18 patient consent or caregiver patient cooperation having a drug to be infused patients who have been hospitalized for at least 48 hours 18 years no limit Both Pregnant patients lactating patients immunocompromised patients Patients with skin and vascular diseases Patients receiving hypertonic serum and patients receiving blood and blood products patients receivingTotal parenteral nutrition Patients with sepsis patients with mental disorders Patients receiving anticoagulants If you have a local infection at the catheter injection site T81.7 T85.7 Vascular complications following a procedure, not elsewhere classified Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts Treatment - Devices Treatment - Devices Intervention group: The serum used in the infusion of drugs will be changed every 48 hours. At the end of 48 hours from the start of serum infusion, 5 cc of each serum was drawn with a syringe and sterile method and sent to the laboratory under sterile conditions and in the shortest possible time and each sample was cultured by a blind laboratory expert. Then count the number of colonies that appear and if more than fifteen microbial growths are seen in each container, the result of positive culture and the corresponding serum will be considered infected. If the number of colonies was less than or equal to 15 and the person was asymptomatic, serum is considered colonization. Control group: The serum control group used in the infusion of drugs will be changed every 24 hours. At the end of 48 hours from the start of serum infusion, 5 cc of each serum was drawn with a syringe and sterile method and sent to the laboratory under sterile conditions and in the shortest possible time and each sample was cultured by a blind laboratory expert. Then count the number of colonies that appear and if more than fifteen microbial growths are seen in each container, the result of positive culture and the corresponding serum will be considered infected. If the number of colonies was less than or equal to 15 and the person was asymptomatic, serum is considered colonization. Number of phlebitis according to Jackson criteria. Timepoint: During the period of hospitalization. Method of measurement: Jackson criteria. Number of cases of serum contamination. Timepoint: 24 hours in the control group and 48 hours in the experimental group. Method of measurement: Response of serum culture sample sent to laboratory. Number of catheter contamination cases. Timepoint: Discharge of the patient or 72 hours after catheter placement or catheter phlebitis. Method of measurement: Response of the catheter sample sent to the laboratory. Sabzevar University of Medical Sciences Approved 2021-03-06 Ethics Committee of Sabzevar University of Medical Sciences Asadabadi sabzvar Razavi Khorasan Iran (Islamic Republic of)