Comparative study of the renal toxicity of dosage regimen containing high and conventional doses of colistin with monitoring of novel biomarkers of acute kidney injury
Reemergence of colistin, an old antibiotic, because of world wide increase in hospital acquired infections due to multi drug resistent gram negative organisms result in more study about its pharmacokinetic and suggestion of new dosing regimen. New regimen include a loading doses of 9 million units and maintenance doses of 4.5 million units every 12 hours, compared to convetional dosing of 1-2 million units every 8 hours. Concern about nephrotoxicity of these high doses leading to design of this randomized controlled trial to compare nephrotoxicity of these two regimens. 40 patients candidate for colistin therapy included and randomized in two 20 patients groups, one group received high dose regimen and another one received low dose regimen. Blood samples was drown on day 1 (before first dose), day 3, 5, 7 and 10 of treatment, serum separated and then stored at - 70 degree centigrade. Cystatin c and NGAL, sensitive biomarkers of early detection of acute kidney injury, was measured and compared in groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090614693N5
Registration date:2014-09-23, 1393/07/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy.
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-09-20, 1394/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the renal toxicity of dosage regimen containing high and conventional doses of colistin with monitoring of novel biomarkers of acute kidney injury
Public title
Comparative study of the renal toxicity of dosage regimen containing high and conventional doses of colistin with monitoring of novel biomarkers of acute kidney injury
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion: candidate for colistin therapy; at least 7 days colistin therapy; age 18-65
Exclusion: chronic kidney injury (GFR<60); Acute kidney injury; BMI>35; patient discontent
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences.
Street address
Niyayesh cross road, Valiasr st.
City
Tehran
Postal code
Approval date
2014-01-21, 1392/11/01
Ethics committee reference number
268
Health conditions studied
1
Description of health condition studied
patients with hospital acquired infections due to multi drug resistant gram negative organisms
ICD-10 code
B96.1
ICD-10 code description
Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified to other chapters
2
Description of health condition studied
patients with hospital acquired infections due to multi drug resistant gram negative organisms
ICD-10 code
A41.8
ICD-10 code description
Other specified sepsis
3
Description of health condition studied
patients with hospital acquired infections due to multi drug resistant gram negative organisms
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
serum cystatin c level
Timepoint
day 1(before first dose), 3, 5, 7, 10
Method of measurement
biochemisty kit
Secondary outcomes
1
Description
change in serum creatinin level and GFR
Timepoint
first 10 days of treatment
Method of measurement
GFR with cockroft gault equation
2
Description
Added at 2016-08-10: Neutrophil gelatinase-associated lipocalin (NGAL)
Timepoint
Added at 2016-08-10: day 1, 3, 5, 7, 10
Method of measurement
Added at 2016-08-10: ELISA kit
Intervention groups
1
Description
In high dose group, the patients receive a loading doses of 9 million units and maintenance doses of 4.5 million units colistin every 12 hours, Blood samples was drown on day 1 (before first dose), day 3, 5, 7 and 10 of treatment, serum separated and then stored at - 70 degree centigrade.
Category
Treatment - Drugs
2
Description
In low dose group, the patients receive 2 million units colistin every 8 hours. Blood samples was drown on day 1 (before first dose), day 3, 5, 7 and 10 of treatment, serum separated and then stored at - 70 degree centigrade.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Dr. Zahra Sahraei
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti university of medical sciences
Full name of responsible person
dr. Jamshid Salamzadeh
Street address
Niyayesh cross road, Valiasr st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Pharmacy, Shahid Beheshti university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Atefeh Ordooei Javan
Position
Resident of Clinical Pharmacy
Other areas of specialty/work
Street address
Niyayesh cross road, Valiasr st.
City
Tehran
Postal code
Phone
+98 21 8820 0118
Fax
Email
atefeh.ordooei.j@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Zahra Sahraei
Position
Assistant professor
Other areas of specialty/work
Street address
Niyayesh cross road, Valiasr st.
City
Tehran
Postal code
Phone
+98 21 8820 0118
Fax
Email
z.sahraei@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)