Comparative study of the effect of oral liquid therapy with intravenous fluid therapy on the adequacy of renal function after angiography and angioplasty
Comparative study of the type of fluid therapy on the adequacy of kidney function in patients undergoing angiography and angioplasty
Design
A clinical trial with a community-based, pragmatic, venous and oral group, with parallel,Without blinding, non-randomized groups
Settings and conduct
The patients are candidates for angiography and angioplasty in Heshmatieyeh Hospital in Sabzevar who are elective and have entry criteria are takes Conscious informed consent and age, weight, creatinine and EF calculates And creatinine below 1.5 is consider normal and the patient's GFR is calculated. The first patient that is candidate for angioplasty and angiography who has been selected to disposal, will be drafted in one of the two groups of venous or oral fluid therapy.We will assign the next patients in each of these two groups, respectively. In all groups, 500 ml of normal saline serum is infusion intravenously 6 hours before the procedure as basal hydration.then, for the oral group 300 cc of mineral water was gived 2 hours before the procedure and 700 cc of mineral water within 6 hours after the procedure, and for the intravenous group 300 cc normal saline was administered 2 hours before the procedure and 700 cc normal saline get infusion within 6 hours after the procedure. the creatinine patient's blood is checked 48 hours after the procedure and Creatinine levels are compared with before intervention
Participants/Inclusion and exclusion criteria
Patients with an EF of more than 35% have creatinine less than 1.5, patients with no ESRD [1]
Intervention groups
Oral and venous fluid therapy in patients undergoing angiography and in patients undergoing angioplasty
Main outcome variables
Creatinine changes before angiography and angioplasty; Creatinine levels after angiography and angioplasty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041722N1
Registration date:2018-12-15, 1397/09/24
Registration timing:registered_while_recruiting
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
Khadijeh Karraby
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7891
Email address
khadijehkarraby68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-03, 1397/09/12
Expected recruitment end date
2019-01-02, 1397/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of oral liquid therapy with intravenous fluid therapy on the adequacy of renal function after angiography and angioplasty
Public title
Comparative study of the effect of oral liquid therapy with intravenous fluid therapy on the adequacy of renal function after Angiography and Angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with EF more than 35%.
Creatinine is less than 1.5.
Patients who do not have ESRD and do not undergo dialysis.
Patients with stable hemodynamic status and blood pressure greater than 90mmHg.
The calculated GFR values are above 30 CC / min / 1.73.
Older people are 18 years of age and under 70 years of age.
Exclusion criteria:
People who have gastrointestinal illness after consulting a gastroenterologist
Patients with kidney problems
Patients taking medications that are effective in kidney function.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Central Organization of Medical Sciences,Asad Abadi Street , Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
IR.MEDSAB.REC.1397.066
Health conditions studied
1
Description of health condition studied
angiography
ICD-10 code
XVIII
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
2
Description of health condition studied
Angioplasty
ICD-10 code
XVIII
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Changes in creatinine before, after angiography, with an increase in cr content of more than 25% of baseline, or more than 0.5 mg / dl of creatinine increase, is considered as an incidence of CIN.
Timepoint
Blood creatinine measurements at the beginning of the study (before the intervention) and 48 hours after the intervention
Method of measurement
The blood creatinine test carried out by the Bt4500 device.
2
Description
Level Of GFR
Timepoint
Before Of Intervention And 48 hours after intervention
Method of measurement
Due to the formula * Cockcroft-Gault
3
Description
Level Of EF
Timepoint
Before Of Intervention
Method of measurement
With an electrocardiograph device
4
Description
Kidney function adequacy
Timepoint
48 hours after intervention
Method of measurement
GFR evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Oral fluid therapy in patients undergoing angiography and angioplasty
Category
Prevention
2
Description
Control group:Venous fluid therapy in patients undergoing angiography and angioplasty
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatieyeh Hospital
Full name of responsible person
Tofighian Tahereh
Street address
Heshmatieyeh Hospital,Asad Abadi Street , Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873140
Phone
+98 51 4401 1601
Email
khadijehkarraby68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Sabzevar - Nuclear Martyrs Boulevard - Above the Mazar-e Martyrs of Anonymous-Prestige of Sabzevar University of Medical Sciences - Deputy of Research and Technology , Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8319
Fax
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Tofighian Tahere
Position
the coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Central Organization of Medical Sciences,Asad Abadi Street , Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1096
Fax
Email
tofighiyan260@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Tofighian Tahere
Position
the coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Central Organization of Medical Sciences,Asad Abadi Street , Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1096
Fax
+98 51 4401 1096
Email
tofighiyan260@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Karraby Khadijeh
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Central Organization of Medical Sciences,Asad Abadi Street , Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873140
Phone
+98 51 4464 7891
Email
khadijehkarraby68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available