Recommendation for Use of Acetylcysteine in Patients Receiving colistin, If Positive Results Were Observed
Design
Randomized Controlled Clinical Trial
Settings and conduct
This study is performed in Alzahra hospital affiliated to Isfahan University of Medical Sciences. Patients who received colistin for a standard dose of 4.5 million units of sodium colistemate every 12 hours for any reason and met the inclusion criteria were randomly divided into two groups (n-acetylcysteine) and control. Patients in the drug group received 600 mg of N-acetylcysteine twice daily for 10 days, starting with colistin, whereas patients in the control group received colistin only. Serum level of creatinine (SCr) and blood urea nitrogen (BUN) as well as creatinine clearance (CrCl) will be recorded before the start of interventions, every other day during the study, and 12 hours after the last dose of vancomycin in 10th day of therapy, as well as serum NGAL levels before the intervention and 5 days after the intervention (Before administration of colistin) will be recorded for all patients. Finally, by means of statistical tests, mean serum creatinine, BUN, CrCl and NGAL measured at time points and the incidence of acute renal injury will be compared between the NAC and control groups according to the number of cases per stage.
Participants/Inclusion and exclusion criteria
50>age > 18 years; receiving Clistin at 4.5 million units every 12 hours; creatinine clearance > 90 ml/min; not having proteinuria and/or hematuria; not having any renal disorder; not using any other nephrotoxic drug; No history of NAC allergy
Intervention groups
Drug Group: Taking N-acetylcysteine 600 mg Twice Daily with Colistin; Control Group: Taking Colistin alone
Main outcome variables
Serum Creatinine; Blood Urea Nitrogen; Creatinine Clearance; Serum Level Of NGAL; The Number of Cases of Acute Kidney Injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N6
Registration date:2019-12-19, 1398/09/28
Registration timing:registered_while_recruiting
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of N-acetylcysteine in the prevention of colistin-induced nephrotoxicity: a randomized controlled clinical trial
Public title
Evaluation of The Effect of N-acetylcysteine in The Prevention of Vancomycin-Induced Renal Disorder
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Take colistin at a dose of 4.5 million units every 12 hours
Creatinine Clearance > 90 ml/min (Based on CKD-EPI Formula)
Exclusion criteria:
Underlying kidney disorder
Receiving other nephrotoxic drugs
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: Blocks of 4 will be used and patients will be assigned to drug and control groups based on the determined sequences in the blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.361
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum Creatinine
Timepoint
At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention
Method of measurement
Spectrophotometry
2
Description
Blood Urea Nitrogen
Timepoint
At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention
Method of measurement
Spectrophotometry
3
Description
Creatinine Clearance
Timepoint
At baseline and 2, 4, 6, 8, and 10 days after initiation of intervention
Method of measurement
CKD-EPI Formula
4
Description
NGAL serum level
Timepoint
At baseline and 5 days after initiation of intervention
Method of measurement
NGAL Measurement Kit
5
Description
The number of patients with acute kidney injury
Timepoint
End of intervention
Method of measurement
counting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: N-acetylcysteine, 600 mg, twice daily, for 10 days, PO
Category
Prevention
2
Description
Control group: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Rasool Soltani
Street address
Soffeh Ave.
City
]sfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-83461
Phone
+98 31 3668 0048
Email
soltani@pharm.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
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 20, Bagh Daryacheh Ave.
City
isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 20, Bagh Daryacheh Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No. 20, Bagh Daryacheh Ave.
City
Isfahan
Province
Isfehan
Postal code
8176776161
Phone
+98 31 3786 5537
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD