Peritonitis Prevention Study - PEPS · - reduce the incidence of peritonitis during the whole study...
Transcript of Peritonitis Prevention Study - PEPS · - reduce the incidence of peritonitis during the whole study...
Planned by:
Ljungman S, Elung Jensen T, Jensen J, Paulsen D,
Os I, Rosenberg M, Petersons A , Stegmayr B,
Johansson A-C, Heimburger O, Hadimeri H,
M. Rydström, and Persson U
Peritonitis Prevention Study - PEPS
– Undersøke om regelmesssig testing av pasientens kunnskap og
praktiske ferdigheter med henblikk på infeksjonsprofylakse vil
kunne redusere hyppigheten av peritonitt.
(www.ClinicalTrials.gov)
Update April 2013
Antall pasienter i uremibehandling
Norsk nyreregister
31 des 2011: 4329 • Tx 3114
• Hd 1029
• Pd 186
• Alder 75+ = 679 (tx 253)
31 des 2006: 3507 • Tx 2500
• Hd 814
• Pd 193
• Alder 75+ = 530 pasienter (tx 166)
Dialysis Modality & Cohort
Significant difference from 100%: ***:p<0.001; **:p<0.01; *:p<0.05 Heaf EuroPD 2011
When does the first peritonitis occur?
26% of the first peritonitis episodes occured within 3 mon,
50% within 6 mon, and 76% within 12 mon after PD start
3 mon
25%
6 mon
50%
12 mon
76%
Primary aim
To study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (”a new model of follow-up”) can:
- prolong the time to first
peritonitis and
- reduce the incidence of peritonitis
during the whole study compared to
standard treatment.
Secondary aim
To study:
- risk factors for peritonitis,
especially diabetes and age
and
- if the new model of follow-up
can reduce technique failure
rate related to peritonitis.
Tertiary aim
To study if the new model of
follow-up can
reduce the time of
hospitalisation
related to peritonitis
compared to standard
treatment
METHODS
Design
A non-commercial, randomized, multicenter study supported by grants from different sources,
which will include 750 incident PD-patients.
The patients will be randomized to:
an intervention group
that will undergo regular follow-up using a new model
a control group
that will be treated according to the routines of the centre
Inclusion criteria
New PD-patients able to perform PD without
assistance (Help with handling of PD bags and exit-site care
is accepted)
Age: 18 years or more
Exclusion criteria
Previous PD-treatment less than 2 years ago
Peritonitis before inclusion
Active malignancy
Taking part in other studies that may influence
the outcome of the PEPS study
Study design
PD-start 1 mon 3 mon 6 mon 24 mon 12 mon 36 mon
Inclusion
Randomisation
Inclusion time: 2010 – 2013 or longer
Study end: One year after inclusion of the last patient
Patient participation time: Up to 3 years
Test
Tests in the follow-up group
1) A practical examination
(PD exchange, hand disinfection using a UV lamp, exit-site care, fixation of catheter)
Goal: 100% correct
2) A questionnaire
with 24 questions with focus on hygiene and prevention of peritonitis
Goal: >80% correct
If the goals are not reached, patients will be retrained until the goals are reached.
Number of randomized patients
April 1, 2013
Country
Apr 1,
2013
Apr 1,
2012
Last 12
months
Estonia 15 13 2
Finland 35 28 7
Latvia 38 28 10
Denmark 37 23 14
Norway 40 24 16
The Netherlands 23 3 20
Sweden 244 186 58
Total 432 305 127
Randomization in Norway
City Apr 1, 2013
Apr 1,
2012
Last 12
months
(Tromsö) left study 2 2 0
Bodö 4 4 0
Skien 3 2 1
Bergen 4 3 1
Kristiansand 1 0 1
Drammen 4 3 1
Lillehammer 7 5 2
Oslo, Ullevål 7 4 3
Tönsberg 4 1 3
Akershus 4 0 4
Sum 40 16
Randomization in Finland
City Apr 1, 2013
Apr 1,
2012
Last 12
months
Jyväskylä 4 4 0
Kajaani 2 2 0
(Hämenlinna) left study 3 3 0
(Pori) left study 2 2 0
Tampere 6 4 2
Kotka 5 3 2
Lahti 13 10 3
Sum 35 7
Randomization in Denmark
City Apr 1, 2013
Apr 1,
2012
Last 12
months
Aarhus, Skejby 5 5 0
Fredericia 5 3 2
Odense 8 5 3
Copenhagen,
Rigshospitalet 12 8 4
Viborg 7 2 5
Sum 37 14
Randomization in the Netherlands
City
Apr 1,
2013
Apr 1,
2012
Last 12
months
Maastricht 0 - 0
Venlo 3 1 2
Amsterdam, AMC 5 2 3
Leiderdorp 3 0 3
Nieuwegein 13 0 13
Sum 24 21
Randomization in Estonia and
Latvia
City
Apr 1,
2013
Apr 1,
2012
Last 12
months
Estonia: Tartu 15 13 2
Latvia: Riga 38 28 10
Randomization in Sweden
City Apr 1, 2013
Apr 1,
2012
Last 12
months
Falun 3 3 0
Gävle 11 11 0
Jönköping 1 1 0
Kalmar 2 2 0
Linköping 4 4 0
Norrköping 0 0 0
Sundsvall 3 3 0
Örebro 5 5 0
Eksjö 3 2 1
Hässleholm 5 4 1
Skövde 14 13 1
Stockholm,
Kungsholmsdialysen 2 1 1
Uppsala 8 7 1
Umeå 4 2 2
Varberg 8 6 2
Borås 17 14 3
Karlstad 5 2 3
Lund 7 4 3
Solna 4 1 3
Sunderbyn 11 8 3
Eskilstuna 15 11 4
Trollhättan 18 14 4
Helsingborg 17 12 5
Gothenburg 36 30 6
Malmö 18 12 6
Danderyd 23 14 9
Sum 244 58
Number of randomized patients to April 2013
2
67
131 140
184
280
203
374
432
154
-50
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jan-
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apr-1
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n
How can the recruitment of
patients be increased?
At the participating PD units: Every new
PD patient should be evaluated for the study.
Further clinics in the Nordic countries
are welcome to take part in the study
Clinics in the UK are now being invited
Ethics permission for
UK: August 2012
28 clinics recently
invited.
So far 4 clinics
(Sheffield, Glasgow,
Manchester RI, and
Derby) are awaiting
local R&D approval.
First data analysis
The Data Safety Monitoring Board will have the
first data analysis performed in May or June
regarding:
Baseline characteristics in the two groups
Some important outcome data