LUST trial progress, March 2015

The Lung Water by Ultra-Sound (US) guided Treatment to prevent death and cardiovascular complications in high risk ESRD patients with cardiomyopathy (LUST) started in March 2013 and, as of today, 20 European Centres are part of the trial. The trial is successfully ongoing and the web-based platform allows smooth data collection and day-by-day central verification of the completeness and quality of data collection by participating centres.
The table below shows the ranking of participating centres according to the dimension of enrolment (updated to 31/03/2015):

  1. Wroclaw, Poland (33 pts.)
  2. Reggio Calabria, Italy (28 pts.)
  3. Maribor, Slovenia (27 pts.)
  4. Homburg/Saar, Germany (26 pts.)
  5. Iasi, Romania (23 pts.)
  6. Barcelona, Spain (21 pts.)
  7. Kallithea, Athens, Greece (20 pts.)
  8. Ioannina, Greece (18 pts.)
  9. Jerusalem, Israel (14 pts.)
  10. Parma, Italy (12 pts.)
  11. Saint-Augustin, France (10 pts.)
  12. Hannover, Germany (6 pts.)
  13. Nancy, France (6 pts.)
  14. Paris, France (6 pts.)
  15. Viareggio, Lucca, Italy (5 pts.)
  16. Fléury-Merogis, France (3 pts.)
  17. Katowice, Poland (3 pts.)
  18. Imola, Italy (3 pts.)
  19. Strasbourg, France (3 pts.)
  20. Madrid, Spain (1 pts.)

The total number of patients enrolled is now 268 (Fig. 1a). Two centres recently withdrew from the study because of organizational problems at local level. The enrolment rate is 12.5 patients/month. With such a rate, the target number of patients (n=500) will be attained only in September 2016 (Fig. 1b). We believe that an extra-effort is needed to accelerate recruitment and remain confident that the target of 500 patients can be reached by 2015. Almost a half of patients included in the study belong to just four centres. We hope that the other centres will soon increase the enrolment rate to reach this achievable goal.

Fig.1A

 

Fig.1B

Fig. 1: The number of patients enrolled at 31 March 2015 (1A) and the time needed to enrol 500 patients (1B)

The performance of centres, assessed in terms of enrolment rate and completeness and quality of data entry into the database (n° of patients * clinical data completeness + n° of patients * instrumental data completeness) is given in Table 1.

To assist participating centres, the coordinating Unit keeps sending a bi-weekly report to study coordinators. These reports highlight problems encountered with the completeness and the quality of data entered into the study database. Contacts with centres are intensified until discrepancies and potential mistakes are corrected/resolved. Furthermore, we have initiated a program of periodical Skype meetings with some problematic centres. The experience with these Skype meetings is quite encouraging because key issues discussed during the Skype connection received better attention by the same centres after these virtual meetings.

We hope to organize a face to face meeting with coordinators of participating centres during the ERA-EDTA Congress in London, eventually, they will soon receive an invitation to this meeting
.

See you in London!

Prof. Carmine Zoccali
EURECA-m Advisor and LUST Study Coordinator

Dr. Claudia Torino
LUST Study Data Manager

Table 1: The performance of centres, assessed in terms of enrolment rate and completeness and quality of data entry into the Database (Update 31/03/2015).

 

Centre

Score

First patient’s registration date

1

Reggio Calabria, Italy

55.24

02/05/2013

2

Wroclaw, Poland

53.88

01/12/2013

3

Maribor, Slovenia

52.92

26/06/2013

4

Homburg/Saar, Germany

48.06

15/07/2013

5

Iasi, Romania

36.76

01/08/2013

6

Parma, Italy

22.23

02/02/2013

7

Ioannina, Greece

21.87

19/02/2013

8

Saint-Augustin, France

15.40

15/09/2013

9

Kallithea, Athens, Greece

10.29

11/03/2014

10

Nancy, France

 9.86

11/12/2013

11

Hannover, Germany

 5.43

10/12/2014

12

Paris, France

5.27

26/06/2014

13

Strasbourg, France

3.00

02/04/2014

14

Imola, Italy

<3.00

29/09/2014

15

Barcelona, Spain

<3.00

14/04/2014

16

Jerusalem, Israel

<3.00

01/01/2014

17

Viareggio, Italy

<3.00

11/03/2015

18

Madrid, Spain

<3.00

18/03/2014

19

Fléury-Merogis, France

<3.00

31/10/2014

20

Katowice, Poland

<3.00

26/01/2015