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Trial registered on ANZCTR


Registration number
ACTRN12612000152820
Ethics application status
Approved
Date submitted
30/01/2012
Date registered
3/02/2012
Date last updated
9/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alteplase v.s. Trisodium Citrate and Infection and Obstruction Incidence of Permanent Tunneled Dialysis Catheters
Scientific title
The incidence of infection and obstruction of newly inserted permanent tunneled dialysis catheters in chronic hemodialysis patients with using alteplase or trisodium citrate as a locking solution after the middle hemodialysis procedure.
Secondary ID [1] 279649 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACIP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The incidence of infection and obstruction of permanent tunneled dialysis catheters 285454 0
infection in dialysis 307315 0
Condition category
Condition code
Renal and Urogenital 285639 285639 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1mg of alteplase per lumen as a locking solution for permanent tunneled dialysis catheter once a week during the whole interdialysis interval (between dialysis procedure No. 2 and 3). Alteplase (1mg/1ml) will be administred into each lumen initially and then follow by saline at a volume adequate to fill the entire luminal volume (declared by manufacturer on each lumen of catheter).
Intervention code [1] 283935 0
Treatment: Drugs
Comparator / control treatment
Trisodium citrate (Citra-LockTM 4%) as a locking solution at a volume to fill each lumen of catheter during interdialysis interval among all three dialysis procedures (including the interval between dialysis No. 2 and 3).
Control group
Active

Outcomes
Primary outcome [1] 286196 0
The incidence of definitive catheter related blood stream infection (CRBSI).
The definition of definite CRBSI =
1. positive blood culture from catheter and peripheral blood and positive culture from discharge or aspirate from exit site or tunnel with identical organism
or
2. positive blood culture and positive culture of catheter segment with identical organism
or
3. positive blood culture and septic thromboflebitis
or
4. positive blood culture from peripheral blood and catheter (with the identical organism) that meet the criteria for differential time to positivity (DTP) = the positivity of catheter blood culture comes at least 2 hours earlier compared to peripheral blood.
Timepoint [1] 286196 0
6 months
Primary outcome [2] 286397 0
The incidence of probable CRBSI.
The definition of probable CRBSI =
1. two or more positive blood cultures (peripheral blood and catheter) with no evidence for source other than catheter
or
2. single positive blood culture (peripheral blood or catheter) for G+ coccus with no evidence for source other than catheter
or
3. strong clinical suspicion of bacterial infection with the source in catheter (symptoms manifesting during dialysis procedure) with the necessary exclusion of other sources (urogenitaly and respiratory tracts)
or
4. positive blood culture from peripheral blood and catheter (with the identical organism) that don?t meet the criteria of DTP for definite CRBSI
Timepoint [2] 286397 0
6 months
Secondary outcome [1] 295364 0
The incidence of catheter malfunction/obstruction that are defined as:
1. max blood flow (BF) 250 ml/min and less for 30 mins and more during one dialysis procedure (max arterial and venous pressure limits of - 250 mmHg and + 250 mmHg respectively)
or
2. mean BF 250 ml/min and less during two consecutive dialysis procedures (max arterial and venous pressure limits of - 250 mmHg and + 250 mmHg respectively)
or
3. reversal of catheter lines as a solution to start the dialysis with BF at least 200 ml/min (max arterial and venous pressure limits of - 250 mmHg and + 250 mmHg respectively)
or
4. inability to initiate dialysis because of obstruction of catheter for at least 200 ml/min even after the reversal of catheter lines (max arterial and venous pressure limits of - 250 mmHg and + 250 mmHg respectively).
Timepoint [1] 295364 0
6 months

Eligibility
Key inclusion criteria
Patients with end stage kidney disease and newly inserted permanent tunneled dialysis catheter. Dialysis prescription = 3 times a week. Agreement with the trial participation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- anticoagulation treatment INR more than 1.4
- platelets count less than 60x109/l
- catheter insertion in vena cava inferior region (femoral vein)
- catheter insertion by a guide-wire exchange procedure
- active pericarditis with pericardial effusion
- known allergy or intolerance to alteplase or trisodium
- citrate pregnancy or breast-feeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with newly inserted permanent tunneled dialysis catheter will be considered for inclusion to the study. If the patient meet the inclusion criteria and sign informed consent, randomization will occur. Patients will be stratified by the centre. They will be assigned a randomization identification number and the study arm will be known only to pharmacy stuff, who will prepare and dispense the locking solution.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random-number table, 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4031 0
Czech Republic
State/province [1] 4031 0

Funding & Sponsors
Funding source category [1] 284533 0
Government body
Name [1] 284533 0
Research Project No. MSM0021620819 awarded by the Ministry of Education, Youth, and Physical Training of the Czech Republic
Address [1] 284533 0
Ministry of Education, Youth, and Physical Training of the Czech Republic, Karmelitska 7, 118 12 Prague, Czech Republic
Country [1] 284533 0
Czech Republic
Primary sponsor type
Individual
Name
Pavlina Richtrova, MD, PhD
Address
Department of Internal Medicine I, Charles University Medical School and Teaching Hospital, alej Svobody 80, 30460 Plzen, Czech Republic
Country
Czech Republic
Secondary sponsor category [1] 283462 0
None
Name [1] 283462 0
Address [1] 283462 0
Country [1] 283462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286405 0
Local Ethics Commitee of Medical School, Charles University Plzen
Ethics committee address [1] 286405 0
Local Ethics Committee (director: Prof. J. Finek, M.D., Ph.D.), Charles University Medical School and Teaching Hospital, alej Svobody 80, 304 60 Plzen, Czech Republic
Ethics committee country [1] 286405 0
Czech Republic
Date submitted for ethics approval [1] 286405 0
Approval date [1] 286405 0
10/11/2011
Ethics approval number [1] 286405 0

Summary
Brief summary
The aim of the study is to test the hypothesis that the application of alteplasis as a locking solution for tunneled dialysis permanent catheter once a week will decrease the incidence of catheter related blood stream infection and will influence the incidence of catheter obstruction/malfunction.
Trial website
not available
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33568 0
Dr Pavlina Richtrova
Address 33568 0
Department of Internal Medicine I, Charles University, Medical School and Teaching Hospital Plzen Alej Svobody 80
Country 33568 0
Czech Republic
Phone 33568 0
+420377103285
Fax 33568 0
Email 33568 0
richtrovap@fnplzen.cz
Contact person for public queries
Name 16815 0
Dr Pavlina Richtrova, MD, PhD
Address 16815 0
Department of Internal Medicine I, Charles University, Medical School and Teaching Hospital Plzen
Alej Svobody 80
Country 16815 0
Czech Republic
Phone 16815 0
+420 377 103 285
Fax 16815 0
Email 16815 0
richtrovap@fnplzen.cz
Contact person for scientific queries
Name 7743 0
Dr Pavlina Richtrova, MD, PhD
Address 7743 0
Department of Internal Medicine I, Charles University, Medical School and Teaching Hospital Plzen
Alej Svobody 80
Country 7743 0
Czech Republic
Phone 7743 0
+420 377 103 285
Fax 7743 0
Email 7743 0
richtrovap@fnplzen.cz

No information has been provided regarding IPD availability
Summary results
No Results