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IRCT20150621022852N3 IRCT 2018-11-29 Shahid Beheshti University of Medical Sciences effect of VitD3 on Kidney and Muscle in Sepsis Effect of single dose Vitamin D3 Injection on Kidney Function and Muscle Mass in Sepsis Patients 2016-11-01 anticipated 20 Complete https://irct.ir/trial/35354 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Patients were randomized using a random number generator to get an IM injection of vitamin D3, Blinding description: Medical staff of ICU who were unaware of randomization injected vitaminD or placebo. Apart from vitD3 injection, other cilinical aspects were same beween the two groups. As the patients and staff were blinded, we had no placebo effect. 2-3 sepsis. Intervention 1: Intervention group: 24 patients who recieved single dose 300,000 IU vit D3 IM. Intervention 2: Control group: 22 patients who recieved placebo (1 cc Normal Saline). Yes - There is a plan to make this available What will be shared: All information about the outcome of the study, will be available after concealment. When: One year after the publication of the study results To whom: Researchers and university students of related fields can access the data after passing the administrative process. Conditions: A study observer appointed by the ethics committee of Shahid Beheshti University of Medical Sciences can request to receive data after being unidentifiable in order to control the ethical aspects of the study. Where to obtain: Head of the Center for Development of Clinical Research - Management of Loghman Hakim Hospital How to obtain: To receive data, please contact the Loghman Hakim Hospital Clinical Development Center. After obtaining permission from the Head of the Research Center and then the Loghman Hakim Hospital, access to patient information and study will be provided. Comments:
public Mohammadreza Hajiesmaeili
Qazvin St. Makhsus St.
Tehran Iran (Islamic Republic of) 8916835837 +98 21 5541 0044 m.hajiesmaeili2018@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohammadreza Hajiesmaeili
Qazvin St. Makhsus St
Tehran Iran (Islamic Republic of) 8916835837 +98 21 5541 0044 m.hajiesmaeili2018@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Critically ill patients within 24 hours of new-onset sepsis Had three out out of four criteria used to explain the systemic inflammatory response syndrome Were expected to stay in the ICU for at least 48 hours 18 years no limit Both Acute Kidney Injury At least two risk factors for AKI Rapidly changing GFR Rapidly changing serum creatinine Rapidly changing cystatin C Pregnancy History of organ transplantation Hypercalcemic (ionized calcium>1.3 mmol/L) Maintenance renal replacement therapy Platelets <30,000 per mm3 (Coagulopathy) International normalized ratio > 3 (Coagulopathy) Treatment - Drugs Placebo Intervention group: 24 patients who recieved single dose 300,000 IU vit D3 IM Control group: 22 patients who recieved placebo (1 cc Normal Saline) Sarcopenic index. Timepoint: before the intervention, 14, 21 days after intervention. Method of measurement: serum creatinine-to-serum cystatin C ratio ×100. Shahid Beheshti University of Medical Sciences Approved 2018-04-07 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)