Evaluation of the protective effect of melatonin on colistin-induced nephrotoxicity in critically ill patients: A randomized, double blinded clinical trial
Evaluation of the melatonin role on colistin-induced acute nephrotoxicity in critically ill patients
Design
Randomized, parallel group, placebo controlled, double blind clinical trial, among 50 patients (25 patients in each group of melatonin or placebo) was designed. Card shuffling was used for randomization.
Settings and conduct
This randomized, clinical trial was designed to evaluate the effect of oral metalonin (3 mg tablet twice daily for 5 days) in the prevention of colistin-induced acute renal injury and compared it with placebo. This study was conducted among critically ill patients admitted to the intensive care unit (ICU) of Alzahra hospital in Isfahan, Iran. Renal injury was assessed according to urinary neutrophil gelatinase-associated lipocalin (NGAL) and serum creatinine changes. This is a double blinded study, that means participants, and the assessors of the outcomes are unaware of the study group, and moreover seemingly identical medications was used in melatonin and placebo groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Adult patients (more than 18 years) who received intravenous colistin
Creatinine clearance ≥ 45 ml/min at study recruitment
Oral tolerance to the drug
Exclusion criteria:
Receiving intravenous collistin or melatonin for at least 2 weeks before study recruitment
Acute kidney injury before study recruitment
Intervention groups
Melatonin group: Administration of melatonin tablet (3 mg) twice daily for 5 days
Placebo group: Administration of placebo tablet twice daily for 5 days
Main outcome variables
Urinary level of neutrophil gelatinasee-associated lipocalin, serum Creatinin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150221021159N3
Registration date:2020-06-23, 1399/04/03
Registration timing:registered_while_recruiting
Last update:2020-06-23, 1399/04/03
Update count:1
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Shadi Farsaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2618
Email address
farsaei@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-09, 1397/09/18
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the protective effect of melatonin on colistin-induced nephrotoxicity in critically ill patients: A randomized, double blinded clinical trial
Public title
The effect of melatonin on colistin-associated nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (more than 18 years) who received intravenous colistin.
Creatinine clearance ≥ 45 ml/min at study recruitment
Oral tolerance to the drug
Exclusion criteria:
Receiving intravenous collistin or melatonin for at least 2 weeks before study recruitment
Acute kidney injury before study recruitment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The pockets containing medications (melatonin and placebo) were coded, and each code was written on the specific card. Thereafter, eligible patient was assigned to each group, randomly by selecting among shuffling cards. So, allocation sequence was concealed until the moment of assignment, and nobody knows what is the next treatment allocation must be. It should be mentioned that participants, health care providers, assessor and data collector unaware of the assigned intervention (allocated codes).
Blinding (investigator's opinion)
Double blinded
Blinding description
Seemingly identical medications were used in placebo and melatonin group. Moreover, participants, health care providers, assessor and data collector unaware of allocated code in each study group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of clinical pharmacy and pharmacy practice, faculty of pharmacy, Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan University of Medical Sciences.
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2018-12-05, 1397/09/14
Ethics committee reference number
IR.MUI.MED.REC.1397.151
Health conditions studied
1
Description of health condition studied
Acute kidney failure
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified
Primary outcomes
1
Description
Acute kidney failure based on changes of urinary Neutrophil gelatinase-associated lipoccalin (NGAL) and serum creatinine levels.
Timepoint
Measurement of urinary NGAL and serum creatinine at the initial of study (before initiation of colistin or intervention) and 5 days after intervention
Method of measurement
ELISA Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Melatonin tablets made in nature made company are administered orally at the dose of 3 mg twice daily for 5 days, on the same date of starting colistin.
Category
Prevention
2
Description
Control group: Placebo tablets made at the faculty of pharmacy with the same appearance as melatonin tablet are prescribed twice daily, for 5 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AlZahra hospital
Full name of responsible person
شادی فرسایی
Street address
Soffeh Blvd, Alzahra hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
شقایق حق جوی جوانمرد
Street address
خیابان هزار جریب، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی اصفهان، ساختمان شماره ۴، معاونت تحقیقات و فناوری دانشگاه
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezar jerib Ave., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7071
Email
Farsaei@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezar jerib Ave., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7071
Email
Farsaei@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezarjerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7071
Email
Farsaei@pharm.mui.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available