Renal Failure Clinical Trial
Official title:
Effect of Incremental Introduction of Dialysis Versus Standard Care in Patients With End-stage Renal Disease: a Feasibility Study
This feasibility study tests if patients find incremental HD acceptable, whether they tolerate the treatment as planned and to evaluate its safety. Over a period of 18-months, 20 participants will be recruited in to the study who are about to start HD therapy for ESRD. The participants will start HD incrementally (incremental HD group) reaching full dose HD over a period of approximately 15 weeks. The outcomes will be compared to a cohort of 40 matched patients who previously started HD in the conventional manner (historical controls, conventional HD group). All patients will be followed-up for 6 months after first dialysis. Participants will be reviewed regularly during this time, and will undergo laboratory and bed-site monitoring tests. Acceptability and tolerance will be tested by documenting the numbers and percentages of patients who agree to participate and continue in the study. Patients who decline the invitation to join the study will be given the opportunity to express their reasons for declining to go on incremental HD (they will not play further part in the study). The safety of incremental HD will be tested by comparing the rates of pre-defined safety events in the incremental HD vs. conventional HD groups. The impact of incremental HD on patients' residual renal function will be monitored using serial 24-hour urine collections, bio-impedance testing will be conducted to estimate changes in fluid load, measurements of quality-of-life will be undertaken by using patient KDQOL-SF v1.3 questionnaires. These tests will be repeated at regular intervals. Blood tests for estimation of residual renal function and markers of renal anemia, bone disease and cardiac load will be performed at regular intervals and will be compared between the two groups (incremental HD vs. conventional HD groups). These measurements will help in the evaluation of impact of incremental HD on patients' health and well-being. The completion rates of these tests will provide important information about whether they should be included in a future larger trial of incremental HD. Participants undergoing incremental HD will be invited to take part in semi-structured interviews aimed at exploring patients' experiences of receiving incremental HD and their participation in the study. Data from this study will be used to test if it is feasible to use deaths (or a combination of deaths and cardiovascular events) as the main outcome measure in a future definitive trial on incremental HD. The data should enable a sample-size calculation for a future full-scale trial.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02763410 -
Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
|
||
| Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
| Completed |
NCT04084301 -
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
|
N/A | |
| Completed |
NCT03292029 -
Pilot Medical Evaluation of the T50 Test
|
N/A | |
| Suspended |
NCT04589065 -
SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)
|
N/A | |
| Completed |
NCT03806998 -
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure
|
Phase 3 | |
| Active, not recruiting |
NCT03672110 -
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
|
Phase 3 | |
| Completed |
NCT02325726 -
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
|
N/A | |
| Completed |
NCT02116270 -
Accelerated Immunosenescence and Chronic Kidney Disease
|
N/A | |
| Completed |
NCT01859273 -
Adherence Enhancement for Renal Transplant Patients
|
N/A | |
| Completed |
NCT01388270 -
Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis
|
Phase 4 | |
| Completed |
NCT00966615 -
The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition
|
Phase 4 | |
| Completed |
NCT01187953 -
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
|
Phase 3 | |
| Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
| Completed |
NCT01008631 -
The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
|
N/A | |
| Completed |
NCT00765661 -
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients
|
Phase 2 | |
| Completed |
NCT00737672 -
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
|
Phase 3 | |
| Completed |
NCT00808691 -
Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit
|
N/A | |
| Recruiting |
NCT00470769 -
The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR
|
N/A | |
| Terminated |
NCT00338455 -
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
|
Phase 2 |