ٍEvaluation the suitable rate of fluid therapy in patients with mild diastolic dysfunction and severe systolic dysfunction
Design
Two arm parallel groups randomised trial on 120 patients with blinded fluid therapy and outcome assessment
Settings and conduct
Patients with severe systolic dysfunction and mild diastolic dysfunction admitted
in Boo Ali Sina hospital for coronary angiography are randomised in two groups
with different fluid therapy protocols .New pulmonary symptoms and signs will be
evaluated after fluid therapy.Patients, research physicians and data analyzers
don't know in which group the patients are involved .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with severe systolic dysfunction(LVEF<30%) and mild diastolic dysfunction
Exclusion criteria: Patients with valvular heart diseases, Patients with pericardial diseases, Patients with infiltrative diseases, Patients with cardiac rhythms other than sinus, Patients with liver diseases, Patients with kidney diseases
Intervention groups
Group 1 with severe systolic dysfunction and mild diastolic dysfunction recieve normal saline 1cc/kg/hr over 10 hours
Group 2 with severe systolic dysfunction and mild diastolic dysfunction recieve half_ normal saline 50cc/hr over 10 hours
Main outcome variables
dyspnea; pulmonary rales
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047849N1
Registration date:2020-06-27, 1399/04/07
Registration timing:retrospective
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Shadi Faghihi Langroudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3365 2781
Email address
sh.faghihi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
2018-09-19, 1397/06/28
Actual recruitment end date
2020-02-08, 1398/11/19
Trial completion date
2020-02-08, 1398/11/19
Scientific title
Comparison between two protocols of fluid therapy in patients with severe systolic dysfunction and mild diastolic dysfunction
Public title
Fluid therapy in patients with mild diastolic dysfunction and severe systolic dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe systolic dysfunction(LVEF<30%)
Patients with mild diastolic dysfunction
Exclusion criteria:
Valvular heart diseases
Pericardial diseases
Heart rhythm other than sinus rhythm
Infiltrative diseases
Kidney disease
Liver disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
130
Actual sample size reached:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, research physician and data analyzers will be unaware of kind of intervention in each group.
Placebo
Used
Assignment
Parallel
Other design features
In this study,the aim group recieved normal saline with rate of 1cc/kg/hr for 10hours and control group recieved half saline with the rate of 50cc/hr for hours.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Science
Street address
Shahid Beheshti Ave.
City
Qazvin
Province
Qazvin
Postal code
3415613911
Approval date
2018-09-18, 1397/06/27
Ethics committee reference number
IR.QUMS.REC.1397.132
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I30-I52
ICD-10 code description
Other forms of heart disease
Primary outcomes
1
Description
Dyspnea
Timepoint
Every hour after beginning fluid therapy
Method of measurement
Asking from the patient
2
Description
Pulmonary rales
Timepoint
0,5 ,10 hours after beginning fluid therapy
Method of measurement
Pulmonary Exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with severe systolic dysfunction and mild diastolic dysfunction who receive 1cc/kg/hr normal saline over 10 hours
Category
Treatment - Other
2
Description
Control group: Patients with severe systolic dysfunction and mild diastolic dysfunction who receive 50cc/hr half saline over 10 hours
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali Sina Hospital
Full name of responsible person
Zohreh Behnamfar
Street address
Boo Ali Sina Avenue
City
Qazvin
Province
Qazvin
Postal code
3413786165
Phone
+98 28 3333 2930
Fax
Email
boali.hospital@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seiied Mehdi Mirhashemi
Street address
Shahid Beheshti Ave, Mavaddat
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
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
Qazvin University of Medical Sciences
Full name of responsible person
Shadi Faghihi Langroudi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No 2, Andisheh 3, Mollasadra Blvd
City
Qazvin
Province
Qazvin
Postal code
3415835435
Phone
+98 28 3365 2781
Email
Sh.faghihi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shadi Faghihi Langroudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 2, Andisheh 3, Mollasadra Ave.
City
Qazvin
Province
Qazvin
Postal code
3415835435
Phone
+98 28 3365 2781
Email
Sh.faghihi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shadi Faghihi Langroudi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No 2, Andisheh 3, Mollasadra
City
Qazvin
Province
Qazvin
Postal code
3415835435
Phone
+98 28 3365 2781
Email
Sh.faghihi@qums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Files of statical analyze will be accessable.
When the data will become available and for how long
Data are accessable 10 months after recording the record.
To whom data/document is available
All of research physicians can access the data.
Under which criteria data/document could be used
Data will be accessable for researchers in order to perform future research esand systematic review
From where data/document is obtainable
Dr.Zohreh Behnamfar
behnamfarzohreh@gmail.com
What processes are involved for a request to access data/document
After receiving the request e_mail ,our colleague,Dr.Z.Behnamfar will send the data as soon as possible.