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IRCT20230414057904N1 IRCT 2024-01-10 Tehran University of Medical Sciences Evaluation of the effect of maintenance serum with the amount of sodium at the limit of isotonic saline on sodium level, blood pressure and acidosis in admitted patients. Evaluation of the effect of maintenance serum with the amount of sodium at the limit of isotonic saline on sodium level, blood pressure and acidosis in PICU patients of Tehran Bahrami Children's Hospital 2022-03-25 anticipated 90 Complete https://irct.ir/trial/69624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are assigned to normal and half-saline groups, one by one, and based on the Block Random Allocation software with variable sizes multiples of 2. Randomization in two strata will be done separately. We write every code on paper and put it in a pocket which its content cannot be read. Every code is allocated to every patient who is included until the end, Blinding description: The legal guardian and/or the patient is aware of participating in the study but, does not know the fluid types. The care provider and the nurse who are not a research member know the fluid type but, the investigator, outcome assessor, and data analyzer do not. N/A Condition 1: Hypertension. Condition 2: Influence of the maintenance fluid (normal vs. half saline) on blood sodium level. Intervention 1: Normal saline maintenance fluid, 4cc/kg.h for first 10kg, 2cc/kg.h for second 10kg, and 2cc/kg.h for third and more 10kg. There is no specific brand to use and it will depend on Bahrami hospital's drugstore. Training sessions is not in our method. Administration time will depend on ICU admission period. The chemical formula is obvious according to drug's name and it is NaCl 0.9%. Intervention 2: Control group: Half saline maintenance fluid, 4cc/kg.h for first 10kg, 2cc/kg.h for second 10kg, and 2cc/kg.h for third and more 10kg. There is no specific brand to use and it will depend on Bahrami hospital's drugstore. Training sessions is not in our method. Administration time will depend on ICU admission period. The chemical formula is obvious according to drug's name and it is NaCl 0.45%. Yes - There is a plan to make this available What will be shared: The information related to the questionnaire, which includes the individual characteristics of the participants and the variables and outcomes, will be shared. When: The access period starts from 1402 To whom: Study documents will be accessible to study reviewers and researchers of academic and scientific centers.بر Conditions: The study documents will be accessible to the reviewers of the project for the purpose of verification without conditions. It will be useful for others (researchers working in academic and scientific institutions) in order to improve the quality of treatment in childrens fild with respect to trustworthiness standards. Where to obtain: Applicants can request the study documents from the researcher through the postal address and e-mail, and they can also interact in person. Email : faezehjahanshahi3@gmail.com Postal code : 1955673933 Address : No. 29,. Sabouri St,. Alborz St., Naft Town,. Artesh Sharq Highway., Imam Ali Highway., Tehran How to obtain: The study documents will be sent to the email address after the request which should be from an ethical committee or reference and with the supervisor professor's permission. Comments:
public Faezeh Jahanshahi
No. 29, Alborz St., Sabouri St., Naft Town, Imam Ali Hwy
Tehran Iran (Islamic Republic of) 1955673933 +98 21 2244 2920 faezehjahanshahi@gmail.com Tehran University of Medical Sciences scientific Faezeh Jahanshahi
No 29 , Shahid Saburi Ave , Alborz Ave , Abadan Blvd , Naft Town , Artesh Shargh Highway , Emam Ali Highway
Tehran Iran (Islamic Republic of) 1955673933 +98 21 2244 2920 faezehjahanshahi3@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 3 months and 18 years Need for injectable serum 3 months 18 years Both Sodium level below 130 mmol/L Sodium level above 150 mmol/L Having diabetes insipidus Diabetic ketoacidosis Kidney disease requiring dialysis Suffering from the disease of high sodium urinary excretion(Addison's disease, congenital adrenal hyperplasia, Barrett's syndrome) Patients before or after neurosurgery Require chemotherapy hydration Severe liver disease Patients who are likely to receive maintenance serum for less than 6 hours I15.8 E87.1 Other secondary hypertension Hypo-osmolality and hyponatremia Treatment - Other Treatment - Drugs Normal saline maintenance fluid, 4cc/kg.h for first 10kg, 2cc/kg.h for second 10kg, and 2cc/kg.h for third and more 10kg. There is no specific brand to use and it will depend on Bahrami hospital's drugstore. Training sessions is not in our method. Administration time will depend on ICU admission period. The chemical formula is obvious according to drug's name and it is NaCl 0.9%. Control group: Half saline maintenance fluid, 4cc/kg.h for first 10kg, 2cc/kg.h for second 10kg, and 2cc/kg.h for third and more 10kg. There is no specific brand to use and it will depend on Bahrami hospital's drugstore. Training sessions is not in our method. Administration time will depend on ICU admission period. The chemical formula is obvious according to drug's name and it is NaCl 0.45%. ُBlood Sodium level. Timepoint: 6,24,48, and 72 hours. Method of measurement: Blood lab test, with the same kit for all patients. Blood pressure. Timepoint: Every hour. Method of measurement: Non-invasive blood pressure monitoring, with appropriate cuff size. Blood PH. Timepoint: hours 6، 24، 48 , 72. Method of measurement: Blood lab test, with the same kit for all patients. Blood bicarbonate level. Timepoint: hours 6، 24، 48 , 72. Method of measurement: Blood lab test, with the same kit for all patients. Tehran University of Medical Sciences Approved 2021-10-11 Mohammad Eftekhari Keshavarz Blvd, Tehran university of medical science, school of medicine, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)