The purpose of this study was to investigate the effects of intravenous laser on the improvement of patients with acute renal injury using urinary NGAL and serum creatinine.
Design
In this randomized clinical trial, 40 patients with intra renal acute renal injury in all three groups of RIFLE were divided into control and treatment groups.
Settings and conduct
Patients with acute renal injury in all three groups of RIFLE who are referred to the Shahdai Tajrish hospital for treatment are included in the criteria for inclusion in the study. All patients are randomly assigned 1: 1 randomly divided into two groups .The group assigned to the subject is buried in dark envelopes. The envelope will be opened by a doctor only after initial evaluations in each person, and neither patients nor clinical evaluators will know their treatment group. Etiology factors include sepsis, rhabdomyolysis, age, diabetes, hypertension, AKI severity and drugs are matched in both groups. Patients undergoing intravenous laser therapy are using infrared radiation. This method is non-thermal and non-toxic, using a continuous infrared beam or near infrared 600 nm with a power output of 5 mW. In this method, the laser light directly irradiates through a sterile disposable catheter. Two millimeters of optical fiber (200 nm in diameter and silicon dioxide) enter the vein and circulate in the circulation. This procedure is just like the injection of serum. Intravenous light red light, in this study with a power of 5 mW for 30 minutes. The intravenous laser is performed for 7 sessions per day. The NGAL level of urine and serum creatinine is measured and recorded before and after treatment. The control group is under the control of Sham Laser.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with acute renal injury with intra renal causes in all RIFLE classes; Full satisfaction for participation in the study and completion of treatment and follow up; Exclusion criteria: Patients with pre renal and post renal acute renal injury; Patients with Glomerulonephritis; Patients requiring an immunosuppressive drug, including lupus; Patients taking omega-3 and corticosteroids in the last month; Pregnant; light-sensitive; malignant;
Intervention groups
Intervention group: Patients underwent intravenous laser radiation using infrared radiation. This method is non-thermal and non-toxic, using a continuous infrared beam or near infrared 600 nm with a power output of 5 mW. In this method, the laser light directly irradiates through a sterile disposable catheter. Two millimeters of optical fiber (200 nm in diameter and silicon dioxide) enter the vein and circulate in the circulation. This procedure is just like the injection of serum. Intravenous light red light, in this study with a power of 5 mW for 30 minutes. The intravenous laser is performed for 7 sessions per day. The NGAL level of urine and serum creatinine is measured and recorded before and after treatment.
Control group: Under Sham Laser.
Main outcome variables
NGAL level of urine; serum creatinine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N30
Registration date:2018-02-10, 1396/11/21
Registration timing:registered_while_recruiting
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Intravascular Laser Therapy on improvement of Acute Kidney Injury(AKI) with Urinary NGAL and Serum Cr
Public title
Effect of intravenous laser on acute renal injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute renal injury with intera renal causes in all classes R, I and F
Complete satisfaction to participate in the study and completion of the therapeutic and follow up process
Exclusion criteria:
Post renal and prerenal acute renal injury
Glomerulonephritis patients
Patients who need an immunosuppressive drug, including lupus
Patients taking omega-3 and corticosteroids in the last month
Pregnant patients
Light sensitive
Malignant patient
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups according to randomized random numbers 1: 1 individual random sampling method. Patients and therapists are not aware of the type of study group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and therapists are not aware of the type of study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.719
Health conditions studied
1
Description of health condition studied
acute renal impairment
ICD-10 code
N17
ICD-10 code description
acute renal impairment
Primary outcomes
1
Description
NGAL urine and serum creatinine
Timepoint
One occasion before assigning patients to treatment groups and one time at the end of treatment
Method of measurement
Laboratory tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients underwent intravenous laser radiation using infrared radiation. This method is non-thermal and non-toxic, using a continuous infrared beam or near infrared 600 nm with a power output of 5 mW. In this method, the laser light directly irradiates through a sterile disposable catheter. Two millimeters of optical fiber (200 nm in diameter and silicon dioxide) enter the vein and circulate in the circulation. This procedure is just like the injection of serum. Intravenous light red light, in this study with a power of 5 mW for 30 minutes. The intravenous laser is performed for 7 sessions per day.
Category
Treatment - Devices
2
Description
Control group: Under Sham Laser.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Esmat Ghanei
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Razaghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Esmat Ghanei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Esmat Ghanei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Esmat Ghanei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.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
Not applicable
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