Hemodialysis Clinical Trial
— IPUF-HDOfficial title:
Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria - At least one of the following: - Average per-session interdialytic weight gain = 4.0 % of their dry weight in the last month; - Inability to consistently achieve dry weight with the current treatment schedule; - Need for additional HD treatments to achieve prescribed dry weight. - Weekly HD sessions - up to three times/week - Age =18 years - Willing and able to give informed consent Exclusion Criteria - Contraindications to peritoneal dialysis - Contraindications to MRI - Uncontrolled diabetes mellitus - Active infections - Non-compliance to hemodialysis prescription - Pre-study serum sodium < 130 mmol/L |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Sequana Medical N.V. |
Canada,
Assimon MM, Wang L, Flythe JE. Failed Target Weight Achievement Associates with Short-Term Hospital Encounters among Individuals Receiving Maintenance Hemodialysis. J Am Soc Nephrol. 2018 Aug;29(8):2178-2188. doi: 10.1681/ASN.2018010004. Epub 2018 May 23. — View Citation
Banshodani M, Kawanishi H, Moriishi M, Shintaku S, Tsuchiya S. Association between Dialysis Modality and Cardiovascular Diseases: A Comparison between Peritoneal Dialysis and Hemodialysis. Blood Purif. 2020;49(3):302-309. doi: 10.1159/000504040. Epub 2019 Dec 18. — View Citation
Canaud B, Kooman J, Selby NM, Taal M, Francis S, Kopperschmidt P, Maierhofer A, Kotanko P, Titze J. Sodium and water handling during hemodialysis: new pathophysiologic insights and management approaches for improving outcomes in end-stage kidney disease. Kidney Int. 2019 Feb;95(2):296-309. doi: 10.1016/j.kint.2018.09.024. — View Citation
Dahlmann A, Dorfelt K, Eicher F, Linz P, Kopp C, Mossinger I, Horn S, Buschges-Seraphin B, Wabel P, Hammon M, Cavallaro A, Eckardt KU, Kotanko P, Levin NW, Johannes B, Uder M, Luft FC, Muller DN, Titze JM. Magnetic resonance-determined sodium removal from tissue stores in hemodialysis patients. Kidney Int. 2015 Feb;87(2):434-41. doi: 10.1038/ki.2014.269. Epub 2014 Aug 6. — View Citation
Flythe JE, Curhan GC, Brunelli SM. Disentangling the ultrafiltration rate-mortality association: the respective roles of session length and weight gain. Clin J Am Soc Nephrol. 2013 Jul;8(7):1151-61. doi: 10.2215/CJN.09460912. Epub 2013 Mar 14. — View Citation
Grieff M, Mamo E, Scroggins G, Kurchin A. The 'Pull' Technique for Removal of Peritoneal Dialysis Catheters: A Call for Re-Evaluation of Practice Standards. Perit Dial Int. 2017 Mar-Apr;37(2):225-229. doi: 10.3747/pdi.2016.00152. — View Citation
Kanda R, Io H, Nakata J, Makita Y, Sasaki Y, Matsumoto M, Wakabayashi K, Tomino Y, Suzuki Y. Evaluation of Long-Term Combination Therapy With Peritoneal Dialysis and Hemodialysis. Ther Apher Dial. 2017 Apr;21(2):180-184. doi: 10.1111/1744-9987.12517. Epub 2017 Feb 10. — View Citation
Kawanishi H, Hashimoto Y, Nakamoto H, Nakayama M, Tranaeus A. Combination therapy with peritoneal dialysis and hemodialysis. Perit Dial Int. 2006 Mar-Apr;26(2):150-4. No abstract available. — View Citation
Kopp C, Linz P, Wachsmuth L, Dahlmann A, Horbach T, Schofl C, Renz W, Santoro D, Niendorf T, Muller DN, Neininger M, Cavallaro A, Eckardt KU, Schmieder RE, Luft FC, Uder M, Titze J. (23)Na magnetic resonance imaging of tissue sodium. Hypertension. 2012 Jan;59(1):167-72. doi: 10.1161/HYPERTENSIONAHA.111.183517. Epub 2011 Dec 5. — View Citation
Machnik A, Neuhofer W, Jantsch J, Dahlmann A, Tammela T, Machura K, Park JK, Beck FX, Muller DN, Derer W, Goss J, Ziomber A, Dietsch P, Wagner H, van Rooijen N, Kurtz A, Hilgers KF, Alitalo K, Eckardt KU, Luft FC, Kerjaschki D, Titze J. Macrophages regulate salt-dependent volume and blood pressure by a vascular endothelial growth factor-C-dependent buffering mechanism. Nat Med. 2009 May;15(5):545-52. doi: 10.1038/nm.1960. Epub 2009 May 3. — View Citation
McIntyre CW. Bimodal dialysis: an integrated approach to renal replacement therapy. Perit Dial Int. 2004 Nov-Dec;24(6):547-53. — View Citation
Obi Y, Rhee CM, Mathew AT, Shah G, Streja E, Brunelli SM, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Residual Kidney Function Decline and Mortality in Incident Hemodialysis Patients. J Am Soc Nephrol. 2016 Dec;27(12):3758-3768. doi: 10.1681/ASN.2015101142. Epub 2016 May 11. — View Citation
Qirjazi E, Salerno FR, Akbari A, Hur L, Penny J, Scholl T, McIntyre CW. Tissue sodium concentrations in chronic kidney disease and dialysis patients by lower leg sodium-23 magnetic resonance imaging. Nephrol Dial Transplant. 2020 Apr 6:gfaa036. doi: 10.1093/ndt/gfaa036. Online ahead of print. — View Citation
Quiroga I, Reddy SP, Bhattacharjya S, Darby CR. Tenckhoff catheters: the pull technique. Nephrol Dial Transplant. 2003 Aug;18(8):1682. doi: 10.1093/ndt/gfg173. No abstract available. — View Citation
Quiroga IM, Baboo R, Lord RH, Darby CR. Tenckhoff catheters post-renal transplantation: the 'pull' technique? Nephrol Dial Transplant. 2001 Oct;16(10):2079-81. doi: 10.1093/ndt/16.10.2079. — View Citation
Ramdeen G, Tzamaloukas AH, Malhotra D, Leger A, Murata GH. Estimates of interdialytic sodium and water intake based on the balance principle: differences between nondiabetic and diabetic subjects on hemodialysis. ASAIO J. 1998 Nov-Dec;44(6):812-7. doi: 10.1097/00002480-199811000-00009. — View Citation
Rao VS, Turner JM, Griffin M, Mahoney D, Asher J, Jeon S, Yoo PS, Boutagy N, Feher A, Sinusas A, Wilson FP, Finkelstein F, Testani JM. First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. 2020 Mar 31;141(13):1043-1053. doi: 10.1161/CIRCULATIONAHA.119.043062. Epub 2020 Jan 8. — View Citation
Santos SF, Peixoto AJ. Sodium balance in maintenance hemodialysis. Semin Dial. 2010 Nov-Dec;23(6):549-55. doi: 10.1111/j.1525-139X.2010.00794.x. — View Citation
Sriperumbuduri S, Biyani M, Brown PA, McCormick BB. Retrospective study of patients on hybrid dialysis: Single-center data from North America. Perit Dial Int. 2020 Mar;40(2):224-226. doi: 10.1177/0896860819887284. Epub 2020 Jan 17. — View Citation
Titze J, Lang R, Ilies C, Schwind KH, Kirsch KA, Dietsch P, Luft FC, Hilgers KF. Osmotically inactive skin Na+ storage in rats. Am J Physiol Renal Physiol. 2003 Dec;285(6):F1108-17. doi: 10.1152/ajprenal.00200.2003. Epub 2003 Jul 29. — View Citation
Wenstedt EFE, Olde Engberink RHG, Vogt L. Sodium Handling by the Blood Vessel Wall: Critical for Hypertension Development. Hypertension. 2018 Jun;71(6):990-996. doi: 10.1161/HYPERTENSIONAHA.118.10211. Epub 2018 Apr 16. No abstract available. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin sodium concentration | Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg. | End of week 4 | |
Primary | Adverse events | Completion of the iPUF treatment without adverse events | iPUF interventions on Week 2, 3 and 4 | |
Secondary | Interdialytic weight gain | Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out | week 1 vs 4, week 1 vs 5-6 | |
Secondary | Total weekly sodium removal with interdialytic peritoneal ultrafiltration | Total weekly sodium removal with peritoneal dialysis in intervention weeks | week 2, 3, 4 | |
Secondary | Total volume of fluid removed with interdialytic peritoneal ultrafiltration | Total volume of fluid removed with peritoneal dialysis in intervention weeks | week 2, 3, 4 | |
Secondary | Home blood pressure | Changes in home blood pressure at baseline vs end of intervention and vs washout | week 1 vs week 4, week 1 vs 5-6 | |
Secondary | Mean intradialytic hemodynamics | Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight | week 1 vs 4, week 1 vs 6 | |
Secondary | Regional wall motion abnormalities | Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis | week 1 vs 4, week 1 vs 6 | |
Secondary | Symptoms | Changes in symptoms as measured with the London Evaluation of Illness questionnaire | week 1 vs 4, week 1 vs 6 | |
Secondary | Infusion pain | Infusion pain as measured with 0-10 visual analog scale | Through study completion, average of all study treatments | |
Secondary | Changes in serum sodium | Post-iPUF change in serum sodium | Through study completion, average of all study treatments |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04892745 -
Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
|
||
Not yet recruiting |
NCT04925674 -
Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.
|
Phase 1 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
Withdrawn |
NCT02904343 -
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study
|
N/A | |
Withdrawn |
NCT01855334 -
L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
|
Phase 4 | |
Completed |
NCT01700465 -
Estimating and Predicting Hemodynamic Changes During Hemodialysis
|
N/A | |
Recruiting |
NCT01195519 -
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis
|
N/A | |
Completed |
NCT00737672 -
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
|
Phase 3 | |
Completed |
NCT00527774 -
Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients
|
N/A | |
Completed |
NCT00942253 -
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
|
Phase 2 | |
Completed |
NCT00850252 -
Use of a Lifeline Graft in the A-V Shunt Model
|
Phase 1/Phase 2 | |
Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
Completed |
NCT00776750 -
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
|
Phase 4 | |
Recruiting |
NCT06351007 -
Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)
|
N/A | |
Withdrawn |
NCT03664141 -
Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)
|
Phase 3 | |
Completed |
NCT03909698 -
Antibiotic Dosing in Patients on Intermittent Hemodialysis
|
||
Recruiting |
NCT03311321 -
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
|
N/A | |
Recruiting |
NCT06098924 -
HD Patients' Depression and Happiness
|
||
Recruiting |
NCT03419923 -
Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage
|
N/A |