Determining the effect of intravenous laser therapy on the recovery process in patients with acute kidney injury using urinary NGAL
Design
A randomized, double-blind, sham-controlled clinical trial with a parallel group design of 40 patients
Settings and conduct
Participants will be given an explanation about the procedure and goals of the project, and written informed consent will be obtained from all patients. Patients will be assigned to two groups using random number generation.
1) Laser treatment group: Patients will undergo intravenous laser therapy for 30 minutes using continuous/pulsed light with a wavelength of 600-1100 nm and an output power of 1-500 mW. The laser light will be directly delivered into the bloodstream through a sterile disposable catheter. This treatment will be performed every other day for 7 sessions.
2) Control group: Patients will undergo sham laser treatment.
Urine NGAL levels, GFR, and urine output will be measured and patients' demographics will be recorded. Laboratory tests including CBC, FBS, lipid and liver enzyme profiles, BUN, Cr, calcium, phosphorus, potassium and sodium will be measured. Evaluations will be performed before the treatment and at the end of the treatment period.
36-Item Short Form survey will be used to assess patients' health-related quality of life.
Participants/Inclusion and exclusion criteria
Patients with intra-renal acute kidney injury due to ATN (including toxic and ischemic interstitial nephritis)
Intervention groups
Control group: 7 sessions of treatment with sham laser
Intervention group: Intravenous laser treatment with infrared or near-infrared radiation (600-1100 nm, power=2 mW, 30 minutes) will be performed every other day for 7 sessions.
Main outcome variables
Urine NGAL levels, GFR, urine output
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N33
Registration date:2020-11-18, 1399/08/28
Registration timing:retrospective
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
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
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-07-23, 1398/05/01
Trial completion date
2019-07-23, 1398/05/01
Scientific title
Investigating the effects of intravenous laser therapy on the recovery process in patients with Acute Kidney Injury (AKI) using urinary NGAL
Public title
Investigating the effects of intravenous laser therapy on the recovery process in patients with Acute Kidney Injury (AKI) using urinary NGAL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with intra-renal acute kidney injury (AKI) due to ATN (including toxic and ischemic interstitial nephritis)
Exclusion criteria:
Patients with pre-renal and post-renal acute kidney failure
Patients with glomerulonephritis
Patients who need immunosuppressive drugs such as patients with Lupus
Patients who had been taking Omega-3 and corticosteroids within the past month
Pregnant patients
Patients with photosensitivity
Patients with malignancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into case and control groups based on randomly generated numbers. Group assignments will be concealed in sequentially numbered dark envelopes. The envelopes will be opened after the preliminary patient evaluation by a physician. Neither the patients nor the clinical evaluator will be aware of the group assignments.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient assessments will be performed before and after the treatments by a competent physician who is not affiliated with the research plan and is unaware of the treatment groups. Patients are not informed about the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University Ethics Committee in Biomedical Research
Street address
Shahid Beheshti University of medical sciences, Daneshjoo Blv, Velenjak
Before the treatment and after the last session of laser therapy
Method of measurement
Measuring the NGAL levels in urine samples
2
Description
Glomerular filtration rate (GFR)
Timepoint
Before the treatment and after the last session of laser therapy
Method of measurement
Using the following equation: (140-age)×(weight)× (0.85 if female)/72×Cr
3
Description
24-hour urine output
Timepoint
Before the treatment and after the last session of laser therapy
Method of measurement
Urine sample
4
Description
Blood urea nitrogen (BUN)
Timepoint
Before the treatment and after the last session of laser therapy
Method of measurement
Blood sample
5
Description
Creatinine
Timepoint
Before the treatment and after the last session of laser therapy
Method of measurement
Blood sample
Secondary outcomes
1
Description
Patient's quality of life (mental and physical health)
Timepoint
Before the treatment and after the last session of laser therapy
Method of measurement
36-Item Short Form Survey
2
Description
Biochemical profile (Calcium, Phosphor, potassium, and sodium levels in blood, complete blood count, fasting blood sugar, total glycerides, total cholesterol, LDL, HDL, AST, ALT, ALKP)
Timepoint
Before the treatment and after the last session of laser therapy
Method of measurement
Patient's blood sample
Intervention groups
1
Description
Control group: 7 sessions of sham laser treatment
Category
Placebo
2
Description
Intravenous laser treatment with red or infrared radiation (wavelength=600-1100 nm, power=2 mW, irradiation time=30 minutes) will be performed in seven sessions, every other day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Sheida Malekian
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
sheida.mlkn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
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
Sheida Malekian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
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
Mohammadreza Razzaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
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
Sheida Malekian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In the article and final report
When the data will become available and for how long
March 2020
To whom data/document is available
All people
Under which criteria data/document could be used
Journal
From where data/document is obtainable
Search
What processes are involved for a request to access data/document
Laser application in medical sciences research center