The SAO Renal Team completed a visit to St. Paulus Hospital, Addis Ababa, February 15-March 2, 2018
Dr. Richard Solazzi, President, Dr. Sandra Watkins, Nephrologist and Renal Director, Mr. Chip Watkins, Engineer, Building Projects Director, Dr. Kaj Johanson, Vascular Surgeon, and Lara Severn, PD Nurse Specialist and Trainer, were present.
The primary focus of the trip was to clarify and support the progress of the PD solution production at Pharmacure, a local pharmaceutical company. To that end the Dr. Richard, Dr. Sandy, Mr. Chip and Nurse Lara, along with Dr. Tesfaye from Zewditu Hospital, met with Mr. Abebe Hagos, Director and Industrial Engineer, and his assistant, a pharmacist. Lara was able to provide information to Mr. Abebe about the mechanics of tubing and bags. The following items were discussed and agreed upon.
- The stability cabinet has been installed and is ready to operate. (This is necessary to conduct the stability tests required by FMACA prior to regulatory approval of a new solution.)
- Two autoclaves are ready to be operated at the appropriate temperature for the dialysate. (This was a necessary adjustment to the autoclaves used for LR production.)
- An additional chemical for quality control testing will be supplied by next week by Epharma.
- Shortly a test to demonstrate that the fluid inside the bag and tubing reaches the appropriate temperature in the autoclave will be performed.
- Said Mohamad and Armando Di Florio from Samed visited the factory last week to discuss filling of the bags. It was determined a smaller steel nozzle will be necessary and this is being manufactured in Addis and will be available next week. Samed has provided 1000 bags for preliminary work, with 10,000-20,000 bags to be provided when full scale production of fluid begins.
- By next week the factory should be ready to produce fluid, fill bags with fluid and place in the stability cabinet for the 3-month stability test.
- At the end of the 3 months the fluid will be examined and providing all is well appropriate regulatory approval will be sought.
- It is anticipated that approval will be expedited and fluid may be ready for clinical use by as early as July.
Once fluid is available we will launch a pilot project of 20-50 patients under the direction of Drs. Momina, Berhanu and Tesfaye. A protocol developed by Drs. Hingorani and Thomas has been approved by the Seattle IRB. This protocol provides for collection of data to inform the effectiveness and potential problems of the peritoneal dialysis program. Consent forms and data collection sheets have been developed. This phase of the project will require extensive advance planning to begin scheduling patients, personnel, ORs, classrooms, clinic rooms, etc. Anca Pauliuc, Renal Program Coordinator at St. Paulus Hospital, will facilitate all planning and scheduling.
The Renal Team, accompanied by Dr. Kaj Johanson, Vascular Surgeon, met with Dr. Wendmagegn to discuss importance of PD solution, availability of consumables and building projects. Mr. Chip and Dr. Richard had a more extensive meeting with Mr. Asfaha Solomon Embaye, Building Project Director, to discuss location and facilities for the Renal Center of Excellence be located at St. Paulus. It is anticipated this will provide teaching facilities, ORs for PD catheter and fistula placement, procedure rooms for renal biopsies and facilities for storing and distributing PD fluid to pharmacies and patients.
Lara, PD nurse, brought some teaching supplies that will allow previously trained PD nurses to practice some hands-on procedures. She has shared photographs and other teaching materials with the trainees. She and the other PD Nurse teachers maintain regular contact with the trainees via email and Facebook.
SAO provided a replacement bulb for the flourenscent microscope.
Dr. Richard and Mr. Chip met with Kidist in Dr. Wendmagegn’s office to formalize the MOU between SAO and St. Paulus. They put together contact lists, schedules and frameworks for future activities.
Dr. Sandy and Anca met with the Pediatric Nephrologists to further discuss how to provide HD and PD, as well as ultimately transplantation, to the pediatric patients. Currently 4 HD machines have been procured to be installed in the new Pediatric Hospital. There was discussion about need for more machines, possible need for a water treatment facility in the pediatric hospital due to distance from the central RO in the renal center, and consideration for CVVH/CVVHD machines to provided acute renal replacement therapy for pediatric patients. A list of needed HD and PD catheters will be generated and consideration will be given to SAO donating some catheters and/or a CVVH machine. Long term hopes for the pediatric renal program include a renal laboratory in the pediatric hospital and pediatric renal transplantation, complete with the services of a pediatric urologist and ID specialist.
A part of the Renal Program has been the construction of AV fistulas for hemodialysis (as well as a few AV grafts) during three separate intensive 10-14 day visits by Dr. Kaj. During these visits each operation has served as a teaching model for a St Paulus surgeon, and at this point a total of 6 surgeons have been trained at fistula surgery techniques to the extent that they are now independent operators (i.e. they can carry out straightforward fistula construction). Continued fistula maintenance procedures, 50 in total, have been an ongoing part of these campaigns. A total of 250 AV fistulas and 10 AV grafts have been constructed in the past 12 months: formal assessment of this experience, including complications, reoperations and likelihood of fistula/graft maturation (actual successful use for dialysis) is being pursued with the assistance of Maria Demopulos, MPH.
An important clinical observation (in fact a unique one to be reported by St Paulus surgeons) is that the Ethiopian patient population has remarkably and consistently small-caliber veins. This reduces the likelihood of fistula maturation and underscores the importance of developing a parallel PD program. Indeed it is our expectation that the St Paulus AV fistula surgeons will become, under Dr. Mary’s guidance, equivalently skilled at PD catheter placement.
Finally, Dr. Sandy had a very positive discussion with Mr. Solomon Ato, administrator of the Kidney Dialysis Charity, who will consider releasing some HD and PD catheters for patient use. These catheters were donated by SAO and have been in storage at the charity.by Mr. Chip and
Future plans include a trip in July 2018 by Mr. Chip and Mr. Isa[DW1] Abdus-Salaam, RO specialist at the Northwest Kidney Center, to conduct the Dialysis Water System Training Program (see below) at St. Paulus Hospital and a trip by the SAO team October 22-November 10.
Previous reports from the last year are attached below to provide further background and information about previous activities of the SAO Renal Program.
PROGRESS REPORT SAO-ST PAULUS RENAL PROJECT OCTOBER-NOVEMBER 2017
The SAO Renal Team completed a visit to St. Paulus Hospital, Addis Ababa, October 23-November 10, 2017.
Dr. Richard Solazzi, President, Dr. Sandra Watkins, Nephrologist and Renal Director, Mr. Chip Watkins, Engineer, Building Projects Director, Lara Severn, PD Nurse Specialist and Trainer, Enas Antony, PD Nurse Trainer, Rupa Ray, research scientist, and Dr. Gustavo, pathology fellow, were present.
The primary focus of this visit was to further the development of a PD program for Ethiopia and solidify SAO’s working relationship with St. Paulus to help with the development of the Renal Center of Excellence.
To this end meetings were held with Anca Pauliuc and other staff at St. Paulus, nephrologists and pediatricians at St. Paulus, Zewditu and Menelik Hospitals, Pharmacure, the factory working on PD fluid production and the construction managers at St. Paulus.
Drs. Rupa and Gustavo provided and installed an inverted fluorescence microscope to be used for immunofluorescent examination of renal biopsy specimens for diagnostic purposes.
Other supplies were donated by SAO, including pediatric O2 masks, bone aspiration needles needed for pediatric fluid resuscitation, a pediatric scale to be used for pediatric HD patients, and Tru-Glide renal biopsy needles.
Nurses Lara and Enas conducted refresher courses for the previously trained PD nurses and provided initial training for five additional PD nurses. This brings the total of PD nurses trained to 21. The Training Manual, now in its 7th revision, continues to be revised and updated based on feedback and perceived conditions in Ethiopia.
Drs. Richard and Sandy, with Mr. Chip, visited the dialysis and RO units at St. Paulus, Zewditu and Menelik Hospitals. It was determined that the technicians at those facilities could benefit from further training in maintenance and trouble-shooting of the RO units. To that end a training program, complete with curriculum, will be planned by Mr. Isa[DW2] Abdus-Salaam, RO specialist at the Northwest Kidney Center, and Mr. Chip.
A very productive meeting was held with Dr. Wendmagegn and his administrative staff to discuss mutual needs and capabilities and to clarify the logistics of SAO’s ongoing involvement with the Renal Center at St. Paulus.
PROGRESS REPORT SAO-ADDIS ABABA MARCH 2017
SAO has completed a visit to Ethiopia 2 March -17 March 2017 to advance this project. During this visit we accomplished the following:
Drs. Richard and Sandy and Engineer Mr. Chip Watkins met with the New Minister of Health, Dr. Yifru. They brought him up to date on all progress and discussed the building for the Renal Center of Excellence at length, sharing architectural plans with him. He stated that this is a national priority, gave it his full support and reiterated that Dr. Daniel Burssa will remain the point person from the Ministry for this Project.
Engineer Mr. Chip continues to work on the building which will house the Renal Center of Excellence. He met with architect, Josef Bereded, who is taking a lead role in this project. Josef arranged for a survey of the property which was completed March 8 and the report is pending. Watkins met with Netsanet, architect with the Ministry of Health. Together with Josef and the architect from St. Paul’s they will review the survey and begin to construct a timeline and cost projection. 5 million birr have been pledged by Dr. Zerihun, with the residual construction costs pledged by the Ministry of Health. Engineer Watkins and Dr. Sandy met with newly appointed CEO, Dr. Alemayehu and newly appointed Medical Director, Dr. Shimeles, at Menelik II. Although previously unaware of the decision to locate the Renal Center building on the Menelik campus, they have now been fully briefed and are supportive provided appropriate funding and support is provided.
A visit was made to Pharmacure Company where PD fluid will be manufactured. All is ready save customs clearance of the stabilization chamber. This clearance can be facilitated by Drs. Zerihun and Daniel Burssa. Once cleared, PD fluid will be produced for the stabilization studies. It will be placed in the chamber for 3 months. If all tests are favorable, paperwork will then be sent to FAHMACA for approval. Once received PD fluid production will begin in earnest. Bags will be supplied by Samed Company to our specifications with appropriate connectors and lines.
8 nurses (6 previously trained and 2 new) were trained by Nurses Lara and Kelly. The training manual developed before the initial training session was further revised based on feed back from the trainees. The students demonstrated proficiency in training patients and their families to perform PD at home and in managing chronic PD patients.
Pediatric Surgeon, Mary Brandt, expert in PD catheter placement, gave lectures to surgeons and nurses about PD catheter placement. She is very invested in returning to Addis when fluid is available to place PD catheters and to give one-on-one training to local surgeons and nephrologists for PD catheter placement.
Visits were made to discuss the PD project with nephrologists, pediatric nephrologists, pediatricians and pediatric surgeons at St. Paul’s, Black Lion, Zewditu and Menelik II Hospitals. All are enthusiastic about the project and eagerly awaiting availability of PD fluid produced in country.
Previously 200 PD catheters of various shapes and sizes were donated to the Kidney Charity in Addis Ababa in preparation for eventual placement in patients. Unfortunately, these catheters are in a locked storeroom at Zewditu Dialysis Center and unavailable to us until permission is received from the Agency of Monitoring and Support.
IRB approval for the pilot project to collect data once patients are identified for PD treatment has been obtained and translated consent forms are available. This work was largely completed by Dr. Sangeeta and Bernadette in Seattle. Local IRB approval has yet to be obtained. An attempt was made to meet Dr. Antbeletes in the research office at Black Lion. We will continue to attempt to reach him and to explore where appropriate local IRB approval should be obtained, whether at Black Lion, other hospitals, Addis Ababa Health Bureau or from the Ministry of Science and Technology.
Most recently the pharma company has been slowed by a production hiatus at the factory. They are now producing IV fluid, but we have no date for start of PD fluid production.
Sandra Watkins, MD
Richard, Solazzi, MD
Chip Watkins, PE
Kaj Johanson, MD