]>
IRCT20230228057559N1 IRCT 2023-03-07 Mashhad University of Medical Sciences Compare the effect of heparin lock and normal saline flushing on central venous catheter patency in patients admitted to the intensive care unit Compare the effect of heparin lock and normal saline flushing on central venous catheter patency in patients admitted to the intensive care unit 2023-04-04 anticipated 90 Complete https://irct.ir/trial/68921 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The selection of the research samples is such that all the people hospitalized in special care units, who have the conditions to enter the study, are selected as the research sample. A table was prepared for the order of patients entering the study. At first, 30 numbers from one to three, 30 numbers from four to six, and 30 numbers from seven to nine were selected from random.org/integers. Then, to randomize this list of 90 numbers, the part related to randomization of lists, website random.org/lists was used. In this way, the patients entering the study are assigned a random number that determines the relevant group. Numbers 1 to 3 are for the normal saline group (group A) and numbers 4 to 6 are grouped for the heparin group with a concentration of 30 units (group B) and numbers 7 to 9 are grouped for the heparin group with a concentration of 50 units (group C), Blinding description: Patients are not aware of their treatment method. Based on the drug preparation protocol, the researcher prepares the studied solutions and codes them as A, B, C. The interventionist (patient-specific nurse), without knowing the identity of these codes, injects solution A to patient A, and in the same way, the rest of the codes are also injected to the patient corresponding to their code. The evaluator (patient-specific nurse) records the opening of the catheter with the corresponding specific code in the patient-specific form. N/A Mechanical complications of central venous catheter in intensive care unit patients. Intervention 1: The first intervention group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, a solution of 30 units of heparin (Alborz Daru Company) in a volume of 2 cc every 8 hours inside Each duct is injected and locked, and then the duct is clamped.The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded. Intervention 2: The second intervention group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, a solution of 50 units of heparin (Alborz Daru Company) in a volume of 2 cc every 8 hours inside Each duct is injected and locked, and then the duct is clamped.The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded. Intervention 3: Control group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, they are flushed with a volume of 10 cc of normal saline every 8 hours and then The conduit is clamped. The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded. 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 There is no further information
public Elahe Saffari Khozani
Ibn Sina St., Doctora Crossroads., University St
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 Saffarike982@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Mohamad Hesam Sharifi Por Bahramen
Ibn Sina Street., Doctor's Crossroads., University Street
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 SharifiPM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All hospitalized patients over 18 years of age hospitalized in the intensive care unit who have a central venous catheter The patient's central venous catheter should be three ducts and the size of the catheter ducts should be 16, 18, 18. The patient is treated with anticoagulants Absence of obvious signs of infection at the catheter insertion site (discharge, redness, and swelling) Place the catheter in the subclavian or internal jugular vein The activated partial thromboplastin time (PTT) is within the normal range Less than 24 hours have passed since the central venous catheter was inserted At the beginning of the study, the site of catheter placement should be free of bleeding 18 years no limit Both Occurrence of infection symptoms at the catheter insertion site during the study Unwanted exit of the catheter from its anatomical location, for example, due to the patient's restlessness Bleeding at the catheter insertion site The patient needs cardiopulmonary resuscitation Occurrence of coagulation disorders and change of PTT outside the normal range T82.5 Mechanical complication of other cardiac and vascular devices and implants Prevention Prevention Prevention The first intervention group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, a solution of 30 units of heparin (Alborz Daru Company) in a volume of 2 cc every 8 hours inside Each duct is injected and locked, and then the duct is clamped.The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded. The second intervention group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, a solution of 50 units of heparin (Alborz Daru Company) in a volume of 2 cc every 8 hours inside Each duct is injected and locked, and then the duct is clamped.The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded Control group: In patients whose central venous catheter has been in place for less than 24 hours and who meet the conditions for entering the study, before clamping the central venous catheter, they are flushed with a volume of 10 cc of normal saline every 8 hours and then The conduit is clamped. The central vein catheter channel is checked every 8 hours for the opening or blockage of the catheter by aspirating with a 10 cc syringe and observing the return of blood and fluids, as well as the presence of signs of infection and bleeding, and the result of the intervention is recorded The duration of the opening of the central venous catheter. Timepoint: The primary outcome (catheter patency) is checked every 8 hours. The length of time the catheter remains is recorded at the end of the study or when the catheter is blocked. Method of measurement: How to set the duration of the central venous catheter open is the clock. Mashhad University of Medical Sciences Approved 2023-01-03 Ethics Committee of Mashhad University of Medical Sciences Daneshgah Ave, Mashhad Town mashhad Razavi Khorasan Iran (Islamic Republic of)