Comparison of low dose PEG (polyethylene glycol) and low dose PEG with Sena grafin regarding bowel preparation quality in patients with chronic kidney disease
Comparison of low dose PEG (polyethylene glycol) and low dose PEG with Sena grafin in the regarding bowel preparation quality in patients with chronic kidney disease
Design
Two arm parallel group, three-blind, randomized by permutation block method, phase 3, design of 122 patients
Settings and conduct
122 patients admitted to Imam Hossein Hospital who were candidates for colonoscopy for any reason and at the same time had chronic kidney disease (during the last three months or more GFR <60 ml / min) were included in the study. The patient and the staff and the doctor performing the colonoscopy did not know the type of solution received.The containing boxes was were the same and without label.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. age of more than 18 years, 2. presence of CKD in patients who are candidates for colonoscopy (GFR < 60 based on MDRD formula).
Exclusion criteria: 1. CKD patients needing dialysis or CKD patients with a GFR of less than 15,
2. Patients who experienced acute kidney injury (AKI) imposed on their CKD condition during hospitalization or before the onset of colon preparation (rise of creatinine more than 0.3 or GFR reductions by 50% in the last 3-4 days), 3. Oliguria and symptoms of dehydration (urine output < 0.5 cc/kg/hour in the last six hours), 4. Any contraindications for colonoscopy, 5. Any severe mental retardation,
6. Pregnancy and breast feeding
Intervention groups
The intervention group received fluid containing Senozoid (90 mg) and 1000 ml of PEG (totally 1100 ml) every 12 hours,24 hours before colonoscopy.The control group received 100 ml of water and 1000 ml of PEG (totally 1100 ml). The containing boxes was were the same and without label.
Comparison of low dose PEG (polyethylene glycol) and low dose PEG with Sena grafin regarding bowel preparation quality in patients with chronic kidney disease
Public title
Investigation of the Effect of Senagraph on colon preparation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Chronic Kidney Disease (GFR<60) who are candidates for colonoscopy
Exclusion criteria:
Patients needing dialysis or Patients with a GFR of less than 15 (Base on MDRD)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
We used block randomization method. Each block size was 2 by 2, and in total 16 blocks were considered. The sequence for packages within each block were:ABBA_BABA_BBAA_ABAB_AABB_BAAB. Then each were marked from 1 to 6 as above.After that
the packages within blocks were sequentially numbered from 1 to 64.The random numbergenerator program was used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients and the ward staff who delivered the medicine to the patients and the doctor who performed the colonoscopy were unaware of the type of medicine. The analyst was also unaware of the type of preparation given during the analysis.one group received fluid containing Senozoid (90 mg) and 1000 ml of PEG (totally 1100 ml) while the other group received 100 ml of water and 1000 ml of PEG (totally 1100 ml). The containing boxes were the same and without label.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Univercity of Medical Sciences
Street address
Koodakyari street.velenjak
City
Tehran
Province
Tehran
Postal code
1234569871
Approval date
2019-11-19, 1398/08/28
Ethics committee reference number
IR.SBMU.MSP.REC.1398.803
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
bowel preparation quality base on Ottawa score
Timepoint
24 hours after receiving the solution
Method of measurement
perform colonoscopy and determine the Ottawa score
Secondary outcomes
1
Description
Blood Urea Nitrogen(BUN)
Timepoint
Before the intervention, 24 hours and 48 hours after the intervention
Method of measurement
Blood biochemistry test
2
Description
Ceratinin(Cr)
Timepoint
Before the intervention, 24 hours and 48 hours after the intervention
Method of measurement
Blood biochemistry test
3
Description
Sodium(Na)
Timepoint
Before the intervention, 24 hours and 48 hours after the intervention
Method of measurement
Blood biochemistry test
4
Description
Potasium(K)
Timepoint
Before the intervention, 24 hours and 48 hours after the intervention
Method of measurement
Blood biochemistry test
Intervention groups
1
Description
"Intervention group": Patients in this group received a solution containing one and a half glasses of Senagraf syrup every 12 hours, each glass of which contained 60 cc and 90 mg of SENOZOID, and with 1000 cc of polyethylene glycol solution. In total it was about 1100 cc of oral solution, received 24 hours ago of colonoscopy
Category
Treatment - Drugs
2
Description
"Control group": Patients in this group received a solution containing 1000 cc of polyethylene glycol solution and 100 cc of water (1100 cc in total) every 12 hours, 24 hours before colonoscopy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Meghdad Sedaghat
Street address
Nezamabad,Madani street,Emam Hossein hospital
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 7343 0000
Email
sedaghat@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Ziai
Street address
Koodakyari street,velenjak
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 6466 3443
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meghdad Sedaghat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Nezamabad,Madani street,Emam Hossein hospital
City
Tehran
Province
Tehran
Postal code
1234569871
Phone
+98 21 7343 0000
Email
sedaghat@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meghdad Sedaghat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Nezamabad,Madani street,Emam Hossein hospital
City
Tehran
Province
Tehran
Postal code
1234569871
Phone
+98 21 7343 0000
Email
sedaghat@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meghdad Sedaghat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Nezamabad,Madani street,Emam Hossein hospital
City
Tehran
Province
Tehran
Postal code
1234569871
Phone
+98 21 7343 0000
Email
sedaghat@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
All data is shared after unidendentifiable people
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Use data to compare with other similar interventions
From where data/document is obtainable
Farzaneh tolouei farzanehtolouei@yahoo.com
What processes are involved for a request to access data/document