Evaluation of vasopressin nasal spray effect on the amount of hypertonic saline required for the treatment of intradialytic hypotension in End-stage renal disease patients
This study aimed to evaluate vasopressin nasal spray’s effect on amount of hypertonic saline required for the treatment of intradialytic hypotension and the incidence of intradialytic hypotension in End-stage renal disease patients. All patients with ESRD undergoing hemodialysis in the hemodialysis ward of Ali ibn Abitalib hospital in zahedan with known symptomatic episodes of intradialytic hypotension in at least 30 % of hemodialysis sessions in the 30 days preceding of study, enrolled to study. Patients with the simultaneous use of other preventive methods for intradialytic hypotension, excluded from study.
15 patients in the interventional group received two puffs of vasopressin nasal spray (Minirin®, 10 µg) 30 minutes before hemodialysis for a month and then as the control group received placebo nasal spray (NaCl 0.9 %) 30 minutes before hemodialysis for a month. Systolic blood pressure and mean arterial blood pressure were measured before dialysis and 1, 2, 3 and 4 hours after dialysis start. A fall in systolic blood pressure by at least 20 mmHg or a decrease in mean arterial pressure by at least 10 mmHg with clinical symptoms of hypotension were considered as intradialytic hypotension. Treatments and given saline volumes were recorded and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060222540N1
Registration date:2015-07-06, 1394/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Iman Poorkeykhaei
Name of organization / entity
Zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 3396
Email address
iman.poorkeykha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
All costs of this study will be paid by the researcher.
Expected recruitment start date
2015-02-09, 1393/11/20
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vasopressin nasal spray effect on the amount of hypertonic saline required for the treatment of intradialytic hypotension in End-stage renal disease patients
Public title
The effect of vasopressin nasal spray on intradialytic hypotension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ESRD patients with known symptomatic episode of intradialytic hypotension in at least 30% of hemodialysis sessions in the 30 days preceding enrollment; Serum sodium levels greater than 140 mEq/L.
Exclusion criteria: History of ischemic heart desease; History of cardiovascular events (MI, CVA, ...); Anemia (HB<10 g/dL); Usage of other treatments for intradialytic hypotension at the same time
Age
From 15 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Khalij Fars highway - Zahedan University of Medical Sciences
City
Zahedan
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
5922
Health conditions studied
1
Description of health condition studied
End stage renal desease patients who underwent hemodialysis treatment
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
2
Description of health condition studied
Intradialytic hypotension
ICD-10 code
I95.8
ICD-10 code description
Other hypotension
Primary outcomes
1
Description
Intradialytic Hypotension
Timepoint
Before hemodialysis and 1, 2, 3 ,4 hours after the start of hemodialysis start
Method of measurement
By Mercury sphygmomanometer - A fall in Systolic Blood Pressure by at least 20 mmHg or a decrease in mean arterial pressure by at least 10 mmHg with clinical symptomes of hypotension after onset of hemodialysis
2
Description
Saline volume
Timepoint
After intradialytic hypotension occures and needes intervertion
Method of measurement
By the given volume of saline (mL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Vasopressin nasal spray, 20 micrograms, 30 minutes before the start of hemodialysis start, for 30 days
Category
Treatment - Drugs
2
Description
Control: Nacl Nasal spary, 30 minutes before the start of hemodialysis, for 30 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Ali ibn Abi Talib hospital in zahedan
Full name of responsible person
Dr Ali Alidadi
Street address
Khalij Fars highway - Ali ibn Abi Talib hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
All costs of this study were be paid by the researcher
Full name of responsible person
Dr Ali Alidadi
Street address
khalij fars highway - Ali ibn abi talib hospital
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
All costs of this study were be paid by the researcher
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Ali Alidadi
Position
Nephrologist
Other areas of specialty/work
Street address
Khalij Fars highway - Ali ibn Abi Talib hospital
City
Zahedan
Postal code
Phone
+98 54 3342 5571
Fax
Email
Dr.alidadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Ali Alidadi
Position
Nephrologist
Other areas of specialty/work
Street address
Khalij Fars highway - Zahedan university of medical sciences
City
Zahedan
Postal code
Phone
+98 54 3342 5571
Fax
Email
Dr.alidadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Iman Poorkeykhaei
Position
Other areas of specialty/work
Street address
No 3, Milan 2 Alley, Daneshgah 41 St, Daneshgah Blvd.
City
Zahedan
Postal code
9816814841
Phone
+98 54 3341 3396
Fax
+98 54 3341 3396
Email
iman.poorkeykha@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)