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IRCT20200812048380N1 IRCT 2020-10-10 Shahid Beheshti University of Medical Sciences Intravenous Hypertonic saline solution in management of patients with Diuretic Resistant Generalized Edema Intravenous Hypertonic saline solution in management of patients with Diuretic Resistant Generalized Edema 2021-01-04 anticipated 28 Complete https://irct.ir/trial/50272 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Personal plane randomization The method of assigning the subjects after applying the entry and exit criteria will be random allocation by permutation block method. The randomization unit is individual. The size of the blocks is 4 and in each block, each intervention group will be repeated twice. As a result, we will have 7 different blocks. Then, using the statistical program in R software version 3.6.1, 7 blocks of 4 will be produced, which will produce a total of 28 sequences. Using this randomly generated list, participants are assigned to one of two study groups, Blinding description: Double blinded(patients and health care providers are kept blinded) Patients dont know about the groups but they are aware of treatment process. People who assess the study are not aware of patients group. 3 GENERALIZED EDEMA RESISTANT TO THERAPY. Intervention 1: Control group: they will undergo with treatment by 250mg fursomide q12h plus 150cc normal saline for 48 hours. Intervention 2: Intervention group: they will undergo with treatment by 250mg fursomide q12h plus 150cc hypertonic saline 3% for 48 hours. Yes - There is a plan to make this available What will be shared: Data are available as questionares When: since data gathering To whom: guidance professors Conditions: as they requested Where to obtain: mahshad ghoddusi MD 09126098165 How to obtain: request by phone Comments:
public Mahshad Ghoddusi
No. 39. Paryab ave.,Takavaran st., Delavaran blvd., reslaat sq
Tehran Iran (Islamic Republic of) 1688937481 +98 21 7745 0199 mahshad.ghoddusi@gmail.com Tehran University of Medical Sciences scientific Mahshad Ghoddusi
No.39., Paryab ave., Takavaran st.,Delavaran Blvd. resalat sq
tehran Iran (Islamic Republic of) 1688937481 +98 21 7745 0199 mahshad.ghoddusi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) The target population for this trial was patients older than 18 years old with diffuse peripheral edema who did not respond adequately to 80 mg oral furosemide. 18 years no limit Both subjects candidate for hemodialysis systolic blood pressure ≤80 mmHg GFR ≤15ml/min serum albumin ≤2.5g/dL serum potassium ≥5.5mEq/L serum sodium greater than 145mEq/L anuric patients (urine volume ≤100 ml per 24 hours Treatment - Drugs Treatment - Drugs Control group: they will undergo with treatment by 250mg fursomide q12h plus 150cc normal saline for 48 hours Intervention group: they will undergo with treatment by 250mg fursomide q12h plus 150cc hypertonic saline 3% for 48 hours Weight loss. Timepoint: daily. Method of measurement: scale. Serum cr. Timepoint: before and after treatment. Method of measurement: blood sample. C systatin. Timepoint: before and after treatment. Method of measurement: blood sample. Shahid Beheshti University of Medical Sciences Approved 2018-05-12 SBMU morality committee No.39, Paryab Ave.,Takavaran St., Delavaran Blvd., Resalat Sq. Tehran Tehran Iran (Islamic Republic of)