Protocol summary

Summary
The aim of this study is to determine and compare the serum sodium and potassium levels as well as hemodynamic changes during and within 24 hours after the percutaneous nephrolithotomy. The inclusion criteria are the age between 15 to 65 years, having normal levels of sodium and potassium, having a kidney stone with a diameter greater than 2 cm and having 1 and 2 risk of anesthesia. Exclusion criteria include having histories of hypertension, diabetes mellitus, ischemic heart disease, renal failure, hyponatremia and hypokalemia and using drugs that affect serum electrolyte. This study is a before and after intervention. Sixty three patients who have the mentioned criteria are recruited. Intervention: During the procedure, intravenous normal saline (0.9%) is infused. After insertion of a urinary catheter in lithotomic situation, the patient is placed in abdomen supine position. Distilled water is used for renal washing in above procedure. The primary outcomes include measuring the patients’ serum levels of sodium and potassium at study recruitment, before renal washing with distilled water, every 60 minutes during washing, after the end of the operation and during the 24 hours post-operation. The secondary outcomes include the measurements of systolic and diastolic blood pressure, percent of arterial blood oxygen saturation and heart rate during the mentioned intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031116948N1
Registration date: 2014-06-22, 1393/04/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-06-22, 1393/04/01
Registrant information
Name
Leila Shaddel
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 455 8145
Email address
shaddel.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of hemodynamic, serum sodium and potassium changes within 24 h after percutaneous nephrolithotripsy surgery
Public title
Evaluation of the changes of blood pressure, serum sodium and potassium levels after percutaneous nephrolithotripsy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria are the age between 15 to 65 years, having normal levels of sodium and potassium, having a kidney stone with a diameter greater than 2 cm and having 1 and 2 risk of anesthesia. Exclusion criteria include having histories of hypertension, diabetes mellitus, ischemic heart disease, renal failure, hyponatremia and hypokalemia and using drugs that affect serum electrolyte. Also, the change in the performing procedure that lead to more absorption of washing liquid is another exclusion criteria.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2014-01-21, 1392/11/01
Ethics committee reference number
ajums.REC.1393030

Health conditions studied

1

Description of health condition studied
Calculus of kidney
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney

Primary outcomes

1

Description
serum level of sodium
Timepoint
before, every 60 minutes during intervention, after the end of the intervention and during the 24 hours post intervention
Method of measurement
meq/L, Laboratory kit

2

Description
serum level of potassium
Timepoint
before, every 60 minutes during washing, after the end of the intervention and during the 24 hours post intervention.
Method of measurement
meq/L- Laboratory kit

Secondary outcomes

1

Description
systolic blood pressure
Timepoint
before, every 60 minutes during intervention, after the end of the intervention and during the 24 hours post intervention
Method of measurement
mmHg, by using blood pressure measurement device

2

Description
Diastolic blood pressure
Timepoint
before, every 60 minutes during intervention, after the end of the intervention and during the 24 hours post intervention
Method of measurement
mmHg, by using blood pressure measurement device

3

Description
percent of arterial blood oxygen saturation
Timepoint
before, every 60 minutes during intervention, after the end of the intervention and during the 24 hours post intervention
Method of measurement
Percent, by laboratory test

4

Description
Heart rate
Timepoint
before, every 60 minutes during intervention, after the end of the intervention and during the 24 hours post intervention
Method of measurement
the number of heartbeat per minute, by hemodynamic monitoring device

Intervention groups

1

Description
The intervention is Percutaneous nephrolithotomy (PCNL), a surgery that is used for the treatment of the kidney stones with large diamater. During this procedure, normal saline as well as distilled water are used for continuous renal washing. During PCNL, intravenous normal saline (0.9%) is infused. After insertion of a urinary catheter in lithotomy situation, the patient is placed in abdomen supine position. Distilled water is used for renal washing in above procedure.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Dr. Amir Salari
Street address
Emam Khomeini Hospital, Emam Khomeini Ave, Ahvaz, Iran
City
Ahvaz

2

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Amir Salari
Street address
Golestan Hospital, Golestan St, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Amir Salari
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3037
Fax
Email
amirsalari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Amir Salari
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave ,Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3037
Fax
Email
amirsalari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Leila Shaddel
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
shaddel.l@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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