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

50

150

250

350

450

550

650

750

jan-

10

apr-1

0

jul-1

0

okt-1

0

jan-

11

apr-1

1

jul-1

1

okt-1

1

jan-

12

apr-1

2

jul-1

2

oct-1

2

jan-

12

apr

-13

jun-

13

sep

-13

dec

-13

mar

-14

jun-

14

sep

-14

dec

-14

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

Good bye