Protocol summary

Study aim
Evaluation of Intravenous Hypertonic saline infusion in treatment of patients with Diuretic Resistant Generalized Edema
Design
This is a randomized, double-blinded clinical trial performed on patients admitted to Imam Hossein Hospital.All participants were evaluated carefully with clinical history, physical examination. Fasting blood samples were drawn to determine serum levels of Na, K, Cl, creatinine, urea, Urinary osmolarity and C-cystatin before and 48 hours after treatment. The body weight of patients assessed in the morning, Digital Scales,before and 48 hours after management.
Settings and conduct
The first one intervention group received 150 ml of hypertonic sodium 3% and 250 mg of furosemide every 12 hours for 48 hours and the second placebo group received normal serum saline 0.9% instead of hypertonic. The change in the Body weight, urine output, blood pressure, uric acid, Urine osmolarity, blood biochemistry features and C-cystine levels were assessed.
Participants/Inclusion and exclusion criteria
The target population for this trial was patients older than 18 years old with diffuse peripheral edema who did not respond adequately to receive 80 mg of furosemide . Subjects candidated of hemodialysis, systolic pressure ≤80 mmHg, GFR ≤15, serum albumin ≤2.5, serum potassium ≥5.5, serum sodium more than 145, and anuric patients (urine volume ≤100 ml per 24 hours)،Patients with comorbidities, as dementia, cerebral vascular disease and inability to give informed consent were excluded, as were patients requiring pacemaker implantation and those with a substance or alcoholic addiction.
Intervention groups
patient with generalized resistant to duretic edema who will undergo treatment with 250 mg fursomide plus 150 cc 3%saline q 12h for 48h
Main outcome variables
weight c-cystatine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200812048380N1
Registration date: 2020-10-10, 1399/07/19
Registration timing: prospective

Last update: 2020-10-10, 1399/07/19
Update count: 0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Mahshad Ghoddusi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7745 0199
Email address
mahshad.ghoddusi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravenous Hypertonic saline solution in management of patients with Diuretic Resistant Generalized Edema
Public title
Intravenous Hypertonic saline solution in management of patients with Diuretic Resistant Generalized Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
SBMU morality committee
Street address
No.39, Paryab Ave.,Takavaran St., Delavaran Blvd., Resalat Sq.
City
Tehran
Province
Tehran
Postal code
1688937481
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.SBMU.retech.rec.1397.520

Health conditions studied

1

Description of health condition studied
GENERALIZED EDEMA RESISTANT TO THERAPY
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
weight loss
Timepoint
daily
Method of measurement
scale

2

Description
serum cr
Timepoint
before and after treatment
Method of measurement
blood sample

3

Description
c systatin
Timepoint
before and after treatment
Method of measurement
blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Control group: they will undergo with treatment by 250mg fursomide q12h plus 150cc normal saline for 48 hours
Category
Treatment - Drugs

2

Description
Intervention group: they will undergo with treatment by 250mg fursomide q12h plus 150cc hypertonic saline 3% for 48 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Imam Hossein Hospital
Full name of responsible person
Mahshad Ghoddusi
Street address
Madani st.
City
tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info@ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziaee PHD
Street address
Arabi st., Daneshjou Blvd.,Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
60
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshad Ghoddusi
Position
nephrology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 39. Paryab ave.,Takavaran st., Delavaran blvd., reslaat sq
City
Tehran
Province
Tehran
Postal code
1688937481
Phone
+98 21 7745 0199
Email
mahshad.ghoddusi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshad Ghoddusi
Position
nephrology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.39., Paryab ave., Takavaran st.,Delavaran Blvd. resalat sq
City
tehran
Province
Tehran
Postal code
1688937481
Phone
+98 21 7745 0199
Email
mahshad.ghoddusi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshad Ghoddusi
Position
nephrology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 39, Paryab ave., Takavaran st.,Delavaran st., Reslat sq
City
tehran
Province
Tehran
Postal code
1688937481
Phone
+98 21 7745 0199
Email
mahshad.ghoddusi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data are available as questionares
When the data will become available and for how long
since data gathering
To whom data/document is available
guidance professors
Under which criteria data/document could be used
as they requested
From where data/document is obtainable
mahshad ghoddusi MD 09126098165
What processes are involved for a request to access data/document
request by phone
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