The effectivenees of N-acetylcysteine (NAC) on accelerating renal failer recovery in patient with leptospirosis in Razi Hospital of Ghaemshahr city 2019
The effectivenes of N-acetylcystein (NAC) on accelerating renal failer recovery in patient with leptospirosis
Design
This study is a two-course clinical and two stage chromosomal trauma that will be performed in a group of 32 patient referred to
Razi Hospital in Ghaemshahr.
Settings and conduct
In this study 64 patients with leptospirosis who had acute renal failure at the same time were randomly assigned to two equal groups receiving routine treatments and the N-acetylcystein receiving group will be divided this study will be a double blind study in which the patient will be the final evaluator of the type of study to be blinded the study population will be people with leptospirosis referred to Razi Hospital in Ghaemshahr who have reached definitive diagnosis based on Microscopic Agglotination Test (MAT) and Enzym-Linked Immonosorbent Assay (ELISA)
Participants/Inclusion and exclusion criteria
Inclusion criteria: people with leptospirosis who have been diagnosed with
ELISA with MAT and have a GFR of less than 60 and consent to participate in the study
No entry criteria: people whit diabetes, people whit underlying liver disease, people white underlying kidney disease and patient who have been hospitalized with sepsis symptoms prior to refferal
Intervention groups
N-acetylcystein tablet intervention group 1200 mg is taken orally every 12 hours for 48 hours and the control group also receives the usual treatment
Main outcome variables
Accelerate the improvment of renal function in leptospirosis patients and improve laboratory indicators of renal function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190727044343N4
Registration date:2020-07-28, 1399/05/07
Registration timing:retrospective
Last update:2020-07-28, 1399/05/07
Update count:0
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Lotfollah Davoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4221 8231
Email address
lotfdavoodi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectivenees of N-acetylcysteine (NAC) on accelerating renal failer recovery in patient with leptospirosis in Razi Hospital of Ghaemshahr city 2019
Public title
The effectiveness of N-acetylcystein (NAC) on accelerating renal failer recovery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Glomerular Filteration Rate (GFR) have less than 60 studies.
People whose leptospirosis has been confirmed by Enzym-Linked Immunosorbent Assay (ELISA) or Microscopic Agglutination Test (MAT) .
Satisfaction to participate in the study.
Exclusion criteria:
Diabetics are excluded from the study.
People with underlying liver disease are excluded from the study.
People with underlying kidney disease excluded from the study.
Patients who have been hospitalized with sepsis symptoms prior to refferal.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patient are divided in to two group of 32 people both of whom receive the usual treatments and the intervention group also receives N-acetylcysteine in addition to the usual therapies. Allocation of even and odd numbers to them is according to the time of hospitalization and the researcher have no information about which patients receive N-acetylcysteine and are given by the nurse. And the patient and the final evaluator will be blind towards study allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mazandaran University of Medical Sciences
Street address
Moallem
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.MAZUMS.REC.1398.1392
Health conditions studied
1
Description of health condition studied
Leptospirosis - Acute renal failer
ICD-10 code
A27
ICD-10 code description
Leptospirosis
Primary outcomes
1
Description
Decreased mean serum creatinine levels.
Timepoint
Measurement of serum creatinine levels on days 0,3 and 7 after initiation of treatment.
Method of measurement
Blood serum sample
Secondary outcomes
1
Description
Improved glomerular filtration rate
Timepoint
0,3and days to start treatment.
Method of measurement
Blood serum sample
Intervention groups
1
Description
Intervention group:The group to individual number is assigned is treated with N-acetylcystein 1200mg every 12 hours for 48 hours po. Pharmaceutical production is Osvah
Category
Treatment - Drugs
2
Description
Control group: The group to which the even number are assinged receives routine appointments.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Lotfollah Davoodi
Street address
Ghaemshahr razi hospital
City
Ghaemshahr
Province
Mazandaran
Postal code
4765686143
Phone
+98 11 4221 8231
Email
lotfdavoodi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Street address
Ghaemshahr Razi Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 4221 8231
Email
lotfdavoodi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghaemshahr Razi Hospital
City
Sari
Province
Mazandaran
Postal code
4765686143
Phone
+98 11 4221 8231
Email
lotfdavoodi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Position
Associate professer
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghaemshahr Razi Hospital
City
Sari
Province
Mazandaran
Postal code
4765686143
Phone
+98 11 4221 8231
Email
lotfdavoodi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Lotfollah Davoodi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghaemshahr Rasi Hospital
City
Sari
Province
Mazandaran
Postal code
4765686143
Phone
+98 11 4221 8231
Email
lotfdavoodi@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
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