]>
IRCT20181105041562N1 IRCT 2018-11-19 Kermanshah University of Medical Sciences comparing crystaloids Clinical trial study of comparison of normal saline and lactated ringer for fluid therapy in emergency department of Imam Reza hospital 2018-12-22 anticipated 1300 Complete https://irct.ir/trial/35194 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: each cluster will be defined as patients of 3 consequent days. clusters will allocate to each group using random number table. the person who is responsible for providing drugs will have allocation list of clusters, Blinding description: there is code of fluid (instead of name of fluid) on fluid pocket labels. Just drug providers knows the code of fluid. 3 patients of emergency department of general hospitals that receive intravenous fluid. Intervention 1: Intervention group: Normal Saline group: patients in this group receive normal saline. volume and speed of fluid will be prescribed by responsible physician that is not dependent of type of crystaloid. name of patient and time of infusion will be recorded on fluid pocket label by nurse. observer will assess all pockets after usage about volume and time of infusion and will record it. Intervention 2: Intervention group: Lactated Ringer group: patients in this group receive normal saline. volume and speed of fluid will be prescribed by responsible physician that is not dependent of type of crystaloid. name of patient and time of infusion will be recorded on fluid pocket label by nurse. observer will assess all pockets after usage about volume and time of infusion and will record it. 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 needs permission of supporting organization
public Ali Aliee
Unit 8, Arian Building, No 65, Hajdayi alley, Golestan, Kermanshah, Iran
kermanshah Iran (Islamic Republic of) 6714638381 +98 83 3825 2948 alialiee@gmail.com Kermanshah University of Medical Sciences scientific Ali Aliee
Unit 8, Arian Building, No 65, Hajdayi alley, Golestan, Kermanshah, Iran
kermanshah Iran (Islamic Republic of) 6714638381 +98 83 3825 2948 alialiee@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) all patients of emergency department that fluid prescribed for them age more than 14 15 years no limit Both contraindication to each of these two fluids (according to FDA guideline) need to another fluid for patient need to infusion of drugs that can't infused with one of these fluids E86.0 Dehydration Treatment - Drugs Treatment - Drugs Intervention group: Normal Saline group: patients in this group receive normal saline. volume and speed of fluid will be prescribed by responsible physician that is not dependent of type of crystaloid. name of patient and time of infusion will be recorded on fluid pocket label by nurse. observer will assess all pockets after usage about volume and time of infusion and will record it. Intervention group: Lactated Ringer group: patients in this group receive normal saline. volume and speed of fluid will be prescribed by responsible physician that is not dependent of type of crystaloid. name of patient and time of infusion will be recorded on fluid pocket label by nurse. observer will assess all pockets after usage about volume and time of infusion and will record it. In hospital death. Timepoint: discharge time. Method of measurement: based on hospital record. Duration of hospitalization. Timepoint: at the end of hospitalization. Method of measurement: based on hospital record. Creatinine clearance. Timepoint: 6 and 24 hours after initiation of IV fluid. Method of measurement: creatinine clearance estimated by the Cockcroft-Gault equation. Kermanshah University of Medical Sciences Approved 2018-09-11 Ethics committee of Kermanshah University of Medical Sciences building No2, Kermanshah University of Medical Sciences, Beheshti Blvd, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)