End Stage Renal Disease Clinical Trial
Official title:
Peridialysis Project: The Influence of Predialysis Factors on the Initial Course of Dialysis
The present study plans to delineate the clinical, biochemical, sociological and
psychological factors. involved in dialysis preparation, and their impact on dialysis
initiation (DI), modality choice and prognosis. In particular the following questions are to
be answered.
1. What factors influence unplanned DI?
2. What factors influence choice of dialysis modality?
3. What factors influence choice of dialysis access?
4. Why do physicians start dialysis?
5. What factors in the predialytic period and its immediate aftermath (the "peridialytic"
period) influence prognosis?
Patients All patients starting active end stage renal disease (ESRD) treatment at the
participating centres and their satellite centres.
No. Patients: 1000.
1. Patients who have received their recent predialysis care at another centre can be
included if the previous centre's notes are available, otherwise not.
2. Patients receiving a preemptive transplant are included, even if the transplant is
performed at another centre. A patient questionnaire is not required for these patients.
3. Africans are excluded (inaccurate estimated glomerular filtration rate (eGFR)
calculation) Each patient is allocated a local identity number (1,2,3….). The local
author keeps a registry of the true patient identity of each identity number for
follow-up purposes. This registry is not to be used in any communication outside the
centre.
Comment: Most patients have known chronic uremia at dialysis start. In a few cases, it is
unknown whether the uremia is acute or chronic. There are two main groups:
1. Acute uremia of unknown origin. Doctors should fill the questionnaire in Table 2, which
can be discarded if the patient recovers renal function within three months.
2. Acute kidney injury (AKI). Most of these patients will recover within three months, so
the questionnaire can wait, and be filled in retrospectively for the few remaining
patients.
Methods
1. Each participating centre fills a Centre Questionnaire, see Table 1.
2. All prescribing doctors fill in a voluntary Physician Questionnaire, see Table 4.
3. The doctor prescribing the first dialysis fills in a Motivation Questionnaire, see Table
2.
4. The local coordinator fills in a Patient Notes Review
1. Birthday
2. Sex
3. Height and weight
4. Renal diagnosis
5. Comorbidity
6. Date and creatinine at referral to nephrology dept.
7. Date and creatinine 6 months before dialysis start
8. Date and creatinine 3 months before dialysis start
9. Date and creatinine at start of dialysis information/choice
10. Date and creatinine at access prescription. Date and creatinine at access creation.
If there are several attempts at access creation, the last attempt is registered.
For unplanned dialysis start, this is often the same date as dialysis start.
11. Date of dialysis start
12. Following values before first dialysis: B-hemoglobin, p- creatinine, urea,
potassium, calcium, phosphate, bicarbonate, albumin
13. Initial dialysis modality (centre hemodialysis (HD)/Home HD/continuous ambulatory
peritoneal dialysis (CAPD)/ automated peritoneal dialysis (APD))
14. Type of start (Planned/unplanned)
15. Reason for unplanned start (primary and (if appropriate) secondary).
16. For hemodialysis patient (HD) patients, initial access (areteriovenous fisula
(AVF)/arteriovenous graft (AVG) /tunneled central venous catheter (CVC)/temporary
CVC)
17. Modality after 3 months (Center HD/Home HD/CAPD/APD/regained
function/Transplanted/Dead)
18. Is the patient alive after 3 months Yes/No. If "No" Date of death.
19. Is the patient alive after 6 months Yes/No.
20. If "No" Date of death.Is the patient alive after 12 months Yes/No. If "No" Date of
death.
21. Was the patient transplanted after inclusion? If so, when?
Responsibilities National coordinators are responsible for translation of protocol to local
language, and compliance with any necessary national regulatory requirements (data protection
agency, ethical committee?) Local representatives: local coordination and follow-up. Patient
notes review. Additional secretarial assistance, paid or unpaid, is permitted.
Definitions
ESRD
A patient has ESRD if any of the following:
1. He receives a transplant
2. The doctor "believes" that he has ESRD at first dialysis
3. He has received >90 days dialysis
4. If the doctor is in doubt whether the patient has acute or chronic renal failure, the
patient is registered as soon as there is no doubt that the patient has ESRD For 3 & 4,
registration is performed retrospectively from the first dialysis day.
Planned dialysis
The patient's first dialysis is planned if:
1. His first hemodialysis uses an AV fistula
2. His first hemodialysis uses a permanent catheter as the patient's permanent access
3. His first peritoneal dialysis is >6 days after catheter placement.
The patient's first dialysis is unplanned if:
1. His first hemodialysis uses a temporary catheter
2. His first hemodialysis uses a permanent catheter as the patient's temporary access (i.e.
a later AV fistula is planned.
3. His first peritoneal dialysis is <7 days after catheter placement.
Renal Diagnoses
1. Shrunken Kidneys of unknown cause
2. Glomerulonephritis
3. Chronic interstitial nephropathy, chronic pyelonephritis and postrenal uremia
4. Polycystic kidney disease
5. Hypertensive/atherosclerotic renal disease
6. Diabetic Nephropathy
7. Other
Causes of unplanned dialysis
1. Late referral
2. Acute uremia
3. Acute progression of chronic uremia
4. Doubt about reversibility
5. Clinical indication despite acceptable biochemistry
6. Fistula problems
7. Delayed planning (Controversial. I recommend dialysis planning at the latest when eGFR
<15 ml/minute. Please use your own definition).
8. Patient non-compliance
9. Patient refused dialysis, but later changed his/her mind
Causes of PD modality
1. Patient choice
2. Cardiac insufficiency
3. HD not possible
Causes of HD Modality
1. Patient Choice
2. Physically incapable of peritoneal dialysis (PD)
3. Mentally incapable of PD
4. Abdominal problems
5. Wish for Home HD
6. PD not considered
Table 1 Center Questionnaire
1. Author:
2. Centre Name:
3. Centre type: University/Non-academic
4. Approximate population covered:
5. No. new ESRD patients/year
6. How many of these
1. Preemptive transplant (%)?
2. PD (%)?
3. HD (%)?
7. What is the
1. PD prevalence (no. patients)?
2. HD prevalence?
8. How many nephrology specialists?
9. Does the department have an official policy concerning preferred initial modality:
1. PD first
2. Home HD first
3. Other (what?)
10. Does the department have an official policy concerning when pretransplant investigations
should be initiated? If so what? If not, is there unofficial consensus? What?
11. Does the department have an official policy concerning when dialysis modality choice is
made? If so what? If not, is there unofficial consensus? What?
12. Does the department have an official policy concerning when AV fistulae/grafts are
prescribed? If so what? If not, is there unofficial consensus? What?
13. Does the department have an official policy concerning when peritoneal dialysis
catheters are prescribed? If so what? If not, is there unofficial consensus? What?
14. Does the department have an official policy concerning when chronic dialysis is
prescribed? If so what? If not, is there unofficial consensus? What?
Table 2. Motivation Questionnaire
You have just prescribed this patient's first dialysis. If you do not believe that the
patient's dialysis requirement is chronic, you do not have to fill in this form Put a "1"
besides the primary reason for starting dialysis today. Put a "2" besides a (possible)
secondary reason for starting dialysis today. Put a "X" besides any other reasons that have
been important in influencing your decision to prescribe dialysis today.
Taste disturbances Pulmonary stasis Social (what?) Dyspnea Practical (what?) (e.g. catheter
protection) Hypertension Pericarditis Oedema Biochemical Cardiac symptoms High
Plasma-Creatinine Fatigue High Urea Anorexia Low glomerular filtration rate (GFR)
Nausea/vomiting High Potassium Cachexia/weight loss Acidosis Itching Low calcium Insomnia
High Calcium Depression High Phosphate Diarrhea Falling GFR Other (what?)
Table 4. Physician Questionnaire What is your age? What is your sex? Are you a nephrology
specialist? How many years have you been a doctor? How many years have you been a nephrology
specialist?
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04076488 -
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
|
N/A | |
Completed |
NCT03289650 -
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
|
Phase 3 | |
Completed |
NCT04042324 -
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01242904 -
Use of a Bimodal Solution for Peritoneal Dialysis
|
Phase 2 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03257410 -
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A | |
Withdrawn |
NCT02130817 -
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
|
Phase 4 | |
Completed |
NCT05540457 -
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
|
N/A | |
Not yet recruiting |
NCT04900610 -
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
|
N/A | |
Recruiting |
NCT02176434 -
Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease
|
N/A | |
Active, not recruiting |
NCT02581449 -
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
|
Phase 2 | |
Completed |
NCT02830490 -
Reliability of Functional Measures in Hemodialysis Patient.
|
N/A | |
Completed |
NCT02215655 -
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
|
N/A | |
Completed |
NCT02832440 -
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
|
N/A | |
Completed |
NCT02832466 -
Quantifying the Deterioration of Physical Function in Renal Patients
|
N/A | |
Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
Recruiting |
NCT01912001 -
Virtual Ward for Home Dialysis
|
N/A |