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IRCT2013121015740N1 IRCT 2014-05-04 Vice chancellor for research, Tehran Univercity of Medcal Sciences Effect of intravenous fluid sodium concentration on plasma sodium in pediatric patients Comparison of the Effects of intravenous fluid with different concentrations of sodium on serum sodium levels in patients admitted to the intensive care unit of Bahrami Children's Hospital in 2012-13. 2012-12-30 anticipated 100 Complete https://irct.ir/trial/14917 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Hyponatremia. Intervention 1: In the intervention group, in children over1 , the maintenance intravenous fluid with the common volume and calculated based on the Holliday-Segar formula containing 100 MEq of sodium per liter has been used and in children under 1, 50 MEq of sodium has been used. In addition to sodium, the intravenous fluid contains potassium at 20 MEq per one liter of fluid and glucose with a concentration of 10 g/L, respectively. The volume of the received fluid will be calculated based on the Holliday-segar formula; thus, for the first 10 kilograms, 100 cc weigh per kilogram of weight and for the second 10 kilogram, 50 cc per kilogram weight and for the rest of the weight, 20 cc per kilogram weight of the intravenous fluid are prescribed during 24 hours. Intervention 2: In the control group, in children over 1 years old the maintenance intravenous fluid with the common volume and calculated through the Holliday-Segar formula containing 50 MEq of sodium per liter has been used and in children under 1 years old, 30 MEq of sodium has been used. In addition to sodium, the intravenous fluid contains potassium at 20 MEq per one liter of fluid and glucose with a concentration of 10 g/L, respectively. The volume of the received fluid will be calculated based on the Holliday-segar formula; thus, for the first 10 kilograms, 100 cc weigh per kilogram of weight and for the second 10 kilogram, 50 cc per kilogram weight and for the rest of the weight, 20 cc per kilogram weight of the intravenous fluid are prescribed during 24 hours.
public Dr. Motahare Aghajani Delavar
Ghasem abad st, Shahid Khaei
Tehran Iran (Islamic Republic of) +98 21 4441 2447 maghajani@razi.tums.ac.ir; aghajani_14@yahoo.com Tehran Univercity of Medcal Sciences scientific Dr. Dariush Fahimi
Ghasem abad st, Shahid Kiaei
Tehran Iran (Islamic Republic of) +98 21 7301 3000 fahimida@sina.tums.ac.ir Tehran Univercity of Medcal Sciences Iran (Islamic Republic of) Inclusion criteria: children in the age range 30 days to 14 years for his doctor prescribe intravenous fluid and pain for at least 24 hours in hospital pediatric intensive care Bahrami,Tehran University of Medical are admitted users. Exclusion criteria: patients with acute or chronic renal parenchymal problems, such as diabetic ketoacidosis and cerebral edema in patients at risk of trauma to the head, heart disease; hypoglycemic patients; patients with abnormal secretion of antidiuretic hormone; diabetes insipidus; pituitary or hypothalamic disorders. patients underwent surgery to have lost a lot of blood during surgery, and cranial thoracic surgery patients; cirrhotic patients; patients with severe malnutrition; diabetes, and his doctor to his patient fluid therapy in a framework designed this study can not reject. Withdrawal criteria; The research indicates that children with higher serum sodium lower than the normal range (135_145); the need to take CPR; being intubated; the death; early oral feeding; or any condition that a doctor's decision to withdraw his case if the study or decide to change intravenous fluids may be excluded. 1 year 14 years Both E87.1 Hypo-osmolality and Hyponatremia Treatment - Other Treatment - Drugs In the intervention group, in children over1 , the maintenance intravenous fluid with the common volume and calculated based on the Holliday-Segar formula containing 100 MEq of sodium per liter has been used and in children under 1, 50 MEq of sodium has been used. In addition to sodium, the intravenous fluid contains potassium at 20 MEq per one liter of fluid and glucose with a concentration of 10 g/L, respectively. The volume of the received fluid will be calculated based on the Holliday-segar formula; thus, for the first 10 kilograms, 100 cc weigh per kilogram of weight and for the second 10 kilogram, 50 cc per kilogram weight and for the rest of the weight, 20 cc per kilogram weight of the intravenous fluid are prescribed during 24 hours. In the control group, in children over 1 years old the maintenance intravenous fluid with the common volume and calculated through the Holliday-Segar formula containing 50 MEq of sodium per liter has been used and in children under 1 years old, 30 MEq of sodium has been used. In addition to sodium, the intravenous fluid contains potassium at 20 MEq per one liter of fluid and glucose with a concentration of 10 g/L, respectively. The volume of the received fluid will be calculated based on the Holliday-segar formula; thus, for the first 10 kilograms, 100 cc weigh per kilogram of weight and for the second 10 kilogram, 50 cc per kilogram weight and for the rest of the weight, 20 cc per kilogram weight of the intravenous fluid are prescribed during 24 hours. Plasma concentrations of sodium. Timepoint: 24 hours after initiation of intravenous fluid. Method of measurement: Sodium concentration in the blood sample. Complications Haypvnatrmy. Timepoint: During and after reading. Method of measurement: Clinical interviews with hospital doctors. Vice chancellor for research, Tehran Univercity of Medcal Sciences Approved 2012-05-21 Medical Ethics Committee of Tehran University of Medical Sciences Keshavarz st.Ghods st. Tehran Iran (Islamic Republic of)