Evaluating the effect of hypertonic saline in edema of ICU patients
Design
Two arm parallel group randomized trial (control and intervention groups), blinded and outcome assessment
Settings and conduct
Admission patients that have 2+ edema or more in ICU of Imam Hossein Hospital in Tehran are divided into two intervention and control groups and evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Admission patients in ICU who have more than 18 years old, Patients that have 2+ edema or more
Exclusion criteria: Sodium more than 155, Hemodialysis patients, Albumin less than 2 mg/dl , Creatinine equal to or more than 1.5 mg/dl , Norepinephrine dependent blood pressure, Blood pressure more than180/100 ,
Intervention groups
According to treatment protocols for patients with edema, the furosemide ampoule is given as a 30-minute infusion. In our study, the control group received the standard treatment and patients in the intervention group received furosemide ampoule plus hypertonic saline.
Main outcome variables
Urine volume, level of edema, APACHE II score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191115045446N1
Registration date:2020-01-01, 1398/10/11
Registration timing:prospective
Last update:2020-01-01, 1398/10/11
Update count:0
Registration date
2020-01-01, 1398/10/11
Registrant information
Name
Samin Salehi jazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8856 3910
Email address
saminsalehi58@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-03, 1398/10/13
Expected recruitment end date
2020-07-03, 1399/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of hypertonic saline in edema of ICU patients
Public title
Evaluating the effect of hypertonic saline in edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Admission patients in ICU who have more than 18 years old
Patients that have 2+ edema or more
Exclusion criteria:
Sodium more than 155
Albumin less than 2 mg/dl
Creatinine equal to or more than 1.5 mg/dl
Hemodialysis patients
Blood pressure more than 180/100
Norepinephrine dependent blood pressure
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization: A random number table was created by using Excel software and using the RND command.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
بیمارستان امام حسین
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.106
Health conditions studied
1
Description of health condition studied
Generalized edema
ICD-10 code
R60.1
ICD-10 code description
Generalized edema
Primary outcomes
1
Description
Patients in Intensive care unit with 2+ edema or more
Timepoint
entrance to study and 2 days after intervention
Method of measurement
Measuring of urine volume and edema
Secondary outcomes
1
Description
APACHE II score
Timepoint
entrance to study
Method of measurement
APACHE II score
Intervention groups
1
Description
Intervention group: receiving 50 ml Hypertonic saline and 20 mg Furosemide TDS for 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بخش مراقبت های ویژه بیمارستان امام حسین
Full name of responsible person
محمد سیستانی زاد
Street address
تقاطع نیایش و ولیعصر, دانشکده داروسازی دانشگاه علوم پزشکی شهید بهشتی, گروه داروسازی بالینی
City
تهران
Province
Tehran
Postal code
1985717443
Phone
+98 21 7343 2309
Email
sistanizadm@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh shams
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 23 87121
Fax
+98 21 8887 3794
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?