Evaluation the effect of melatonin in prevention of vancomycin induced nephrotoxicity in critically ill patients: A randomized controlled clinical trial
Evaluation of the melatonin role on vancomycin-induced acute nephrotoxicity in critically ill patients
Design
Randomized, double blinded, placebo controlled clinical trial was conducted among 41 patients (20 patients in melatonin group and 21 patients in control group). Random number table was used for randomization.
Settings and conduct
This randomized, clinical trial is performed in intensive care unit (ICU) of Al-Zahra hospital, Isfahan. This study was designed to evaluate the effect of oral metalonin (3 mg tablet twice daily for 7 days) and comparison with placebo, in the prevention of vancomycin-induced acute renal injury, according to serum Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine level 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 who received intravenous vancomycin, creatinine clearance ≥ 45 milliliter per minute at study recruitment, and oral tolerance to the drug.
Exclusion criteria: Receiving intravenous vancomycin or melatonin for at least 2 weeks before study recruitment, acute kidney injury before study recruitment
Intervention groups
Melatonin group: Administration of 3 mg melatonin tablet twice daily for 7 days
Placebo group: Administration of placebo tablet twice daily for 7 days
Main outcome variables
Serum level of Neutrophil gelatinasee-associated lipocalin, serum creatinin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150221021159N4
Registration date:2020-06-27, 1399/04/07
Registration timing:retrospective
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
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
2018-07-23, 1397/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-07-23, 1398/05/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
Evaluation the effect of melatonin in prevention of vancomycin induced nephrotoxicity in critically ill patients: A randomized controlled clinical trial
Public title
valuation the effect of melatonin in prevention of vancomycin induced nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients who received intravenous vancomycin.
Creatinine clearance more than 45 milliliter per minute at study recruitment
Oral tolerance to the drug
Exclusion criteria:
Receiving intravenous vancomycin 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:
40
Actual sample size reached:
41
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
Bldg No. 4, Isfahan University of Medical Sciences and Health Services, Hizar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-25, 1397/08/03
Ethics committee reference number
IR.MUI.REC.1395.3.861
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 serum neutrophil gelatinase-associated lipocalin (NGAL) levels.
Timepoint
At the initial of study (before initiation of colistin) and 7 days after intervention.
Method of measurement
ELISA Kit
2
Description
Acute kidney failure based on changes of serum creatinine levels.
Timepoint
At the initial of study (before initiation of colistin) and 7 days after
Method of measurement
Creatinine assay 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 7 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 7 days