Protocol summary
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Study aim
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Evaluation of the melatonin and N-acetyl cysteine role on colistin-induced acute nephrotoxicity in critically ill patients
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Design
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The randomized, parallel-group, controlled clinical trial, among 51 patients (17 patients in each group of melatonin, N-acetyl cysteine, or control) was designed. Card shuffling was used for randomization.
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Settings and conduct
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This randomized clinical trial was designed to evaluate the effect of melatonin (3 mg tablet twice daily for 5 days) and N-acetyl cysteine in the prevention of colistin-induced acute renal injury and compared it with control group. 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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Melatonin group: Administration of melatonin tablet (3 mg) twice daily for 5 days
N-acetyl cysteine group: Administration of NAC tablet (600 mg) twice daily for 5 days
Control group: No intervention was conducted in addition to standard care to prevent colistin-induced nephrotoxicity
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Main outcome variables
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Urinary level of neutrophil gelatinasee-associated lipocalin, serum Creatinin level
General information
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Reason for update
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The high prevalence of N-acetyl cysteine (NAC) prescription for critically ill patients in our study setting, could be an important confounding factor for final analysis due to NAC's potential benefit of reducing the urinary neutrophil gelatinase-associated lipocalin (NGAL) level. Therefore, we decided to compare its effect on colistin-induced nephrotoxicity prevention in the separated group.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150221021159N3
Registration date:
2020-06-23, 1399/04/03
Registration timing:
registered_while_recruiting
Last update:
2021-04-05, 1400/01/16
Update count:
1
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Registration date
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2020-06-23, 1399/04/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-09, 1397/09/18
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Expected recruitment end date
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2020-09-22, 1399/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the protective effect of melatonin and N-acetyl cysteine on colistin-induced nephrotoxicity in critically ill patients: A randomized, controlled clinical trial
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Public title
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The effect of melatonin and N-acetyl cysteine on colistin-associated nephrotoxicity
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
51
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Numbers from 1 to 51 were written on the separated cards, and 17 cards were assigned to each group of melatonin, N-acetyl cysteine, and control. These cards were placed in the box, and one card was selected randomly from these shuffled cards for each eligible patient on the study recruitment day. According to the number of the chosen card, patients were categorized into a specific group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-05, 1397/09/14
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Ethics committee reference number
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IR.MUI.MED.REC.1397.151
Health conditions studied
1
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Description of health condition studied
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Acute kidney failure
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ICD-10 code
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N17.9
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ICD-10 code description
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Acute kidney failure, unspecified
Primary outcomes
1
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Description
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Acute kidney failure based on changes of urinary Neutrophil gelatinase-associated lipoccalin (NGAL) and serum creatinine levels.
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Timepoint
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Measurement of urinary NGAL and serum creatinine at the initial of study (before initiation of colistin or intervention) and 5 days after intervention
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Method of measurement
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ELISA Kit
Intervention groups
1
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Description
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First 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.
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Category
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Prevention
2
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Description
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Control group: No intervention was conducted in addition to standard care to prevent colistin-induced nephrotoxicity
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Category
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N/A
3
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Description
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Second intervention group: N-acetyl cysteine tablet are administered orally at the dose of 600 mg twice daily for 5 days, on the same date of starting colistin.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available