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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2017/09/009675 |
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Date of registration:
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07-09-2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A clinical trial comparing two different modes of blood purification in patients with recent onset kidney shut down due to some illness
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Scientific title:
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Comparing intermittent online hemodiafiltration and conventional intermittent hemodialysis in patients with AKI and SIRS, a prospective randomized controlled trial |
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Date of first enrolment:
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15-09-2017 |
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Target sample size:
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80 |
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Recruitment status: |
Not Yet Recruiting |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20158 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Saurabh nayak
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Address:
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Department of nephrology,
C block, level 1,
PGIMER,
Chandigarh
160015
Chandigarh, CHANDIGARH
India |
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Telephone:
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9878943178 |
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Email:
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saurabhnayak2012@gmail.com |
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Affiliation:
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PGIMER, Chandigarh |
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Name:
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Saurabh nayak
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Address:
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Department of nephrology
C block, level 1,
PGIMER
Chandigarh
160015
Chandigarh, CHANDIGARH
India |
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Telephone:
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9878943178 |
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Email:
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saurabhnayak2012@gmail.com |
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Affiliation:
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PGIMER, Chandigarh |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. AKI stage 3 of KDIGO classification or Acute on CKD patients fulfilling standard criteria for requirement of renal replacement therapy
2. Presence of SIRS, fulfilling at least 2 out of 4 criteria
Exclusion criteria: 1. Patients with hypotension requiring more than single inotropes
2. CKD and post renal transplant patients already on some form of renal replacement therapy
3. Indication of dialysis, toxin or drug removal
4. AKI patients with suspected or confirmed Glomerulonephritis, vasculitis or obstructive AKI
5. Terminal illness with associated life expectancy less than 2 months
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Acute kidney injury patients requiring renal replacement therapy
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Intervention(s)
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Intervention1: Online intermittent hemodiafiltration: This is a type of dialysis machine which involves both convective and diffusive clearances.
Control Intervention1: Conventional intermittent hemodialysis: This is a type of dialysis machine which utilises only diffusive clearance.
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Primary Outcome(s)
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1. To examine the feasibility of conducting a larger study that will determine whether convective clearance confers improved outcome as compare to diffusive clearance using intermittent modes of RRT
2. To compare outcome in terms of renal recovery in patients with AKI and SIRS, undergoing online hemodiafiltration vs conventional hemodialysisTimepoint: 1 month
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Secondary Outcome(s)
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Mortality benefit
Timepoint: 1 month
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Change in serum cytokine concentration (IL6)Timepoint: 7 days
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Change in body fluid levels as assessed by bioimpedance machineTimepoint: 7 days
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Change in qSOFA scoreTimepoint: 7 days
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Secondary ID(s)
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U1111-1201-4984
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Source(s) of Monetary Support
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Post graduate institute of medical education and research, sector 12, Chandigarh
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Ethics review
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Status: Approved
Approval date: 25/07/2017
Contact:
Institutional ethics committee, PGIMER, Chandigarh
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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