Survey of changes in serum markers of tissue damage after Extra corporeal shock wave lithotripsy in patients with kidney stones referred to lithotripsy center of Zabol in 1395
Objectives: investigate the effect of extracorporeal shock wave lithotripsy (ESWL) on changes in serum factors of tissue damages in patients with kidney stones. Design: analytic epidemiological study.
Setting and conduct: 120 patients with kidney stone referred to Lithotripsy Clinic's in Amiralmomenin (AS) Hospital of Zabol, Iran, are selected by convenience sampling method.
Inclusion criteria: having age between 12 to 70 years. exclusion criteria: chronic kidney disease and liver; pancreatitis; infections.
Intervention:
The overall aim of this is to In total, Inclusion criteria are having kidney stones and age between 12 to 70 years . Exclusion criteria include chronic kidney and liver diseases; pancreatitis and infections. Demographic information of the patients is recorded and then 5 cc of blood sample are collected before lithotripsy and 3 hours and 24 hours after ESWL and then are transferred into clot activator tube to the hospital laboratory. main outcome measures Variables: enzymes of alanine aminotransferase; aspartate aminotransferase; alkaline phosphatase; amylase; lipase; troponin I (cardiac enzyme); cpk-mb and PK-total; as well as bilirubin and albumin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082328927N2
Registration date:2016-11-15, 1395/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Fatemeh Khajehmahmoud
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1400
Email address
khajeh.f@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zabol University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-09-18, 1395/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of changes in serum markers of tissue damage after Extra corporeal shock wave lithotripsy in patients with kidney stones referred to lithotripsy center of Zabol in 1395
Public title
changes in serum markers of tissue damage after Extra corporeal shock wave lithotripsy in patients with kidney stones
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: having age between 12 to 70 years.
exclusion criteria: chronic kidney disease and liver; pancreatitis; infections.
Age
From 12 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Zabol University of Medical Sciences
Street address
University of Medical Sciences, St. Martyr Bagheri, Zabol.
City
Zabol
Postal code
009861663335
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
Zbmu.1.rec.1394.144
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
Alanine aminotransferase
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
2
Description
Aspartate aminotransferase
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
3
Description
Alkaline phosphatase
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
4
Description
amylase
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
5
Description
Lipase
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
6
Description
Cardiac enzyme troponin I
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
7
Description
Cpk-mb enzymes
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
8
Description
The enzyme CPK-total
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
9
Description
Bilirubin
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
10
Description
albumin
Timepoint
before ESWL; 3 and 24 houre after ESWL
Method of measurement
Blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Demographic information of the patients is recorded and then before lithotripsy and 3 hours and 24 hours after ESWL 5 cc of blood sample are collected and then are transferred into clot activator tube to the hospital laboratory.