search
Back to results

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients (IPUF-HD)

Primary Purpose

End Stage Renal Disease on Dialysis, Hemodialysis, Peritoneal Dialysis

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Interdialytic peritoneal ultrafiltration with 10% dextrose solution
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interdialytic peritoneal ultrafiltration

Arm Description

Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks

Outcomes

Primary Outcome Measures

Skin sodium concentration
Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
Adverse events
Completion of the iPUF treatment without adverse events

Secondary Outcome Measures

Interdialytic weight gain
Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out
Total weekly sodium removal with interdialytic peritoneal ultrafiltration
Total weekly sodium removal with peritoneal dialysis in intervention weeks
Total volume of fluid removed with interdialytic peritoneal ultrafiltration
Total volume of fluid removed with peritoneal dialysis in intervention weeks
Home blood pressure
Changes in home blood pressure at baseline vs end of intervention and vs washout
Mean intradialytic hemodynamics
Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
Regional wall motion abnormalities
Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
Symptoms
Changes in symptoms as measured with the London Evaluation of Illness questionnaire
Infusion pain
Infusion pain as measured with 0-10 visual analog scale
Changes in serum sodium
Post-iPUF change in serum sodium

Full Information

First Posted
October 13, 2020
Last Updated
August 30, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Sequana Medical N.V.
search

1. Study Identification

Unique Protocol Identification Number
NCT04603014
Brief Title
Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients
Acronym
IPUF-HD
Official Title
Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Sequana Medical N.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Hypothesis: Interdialytic peritoneal ultrafiltration (iPUF) via Tenckhoff peritoneal dialysis catheter using 10% Dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent HD patients. Overview: This is a prospective, interventional pilot study from the London Health Sciences Centre (LHSC) prevalent HD population. Study patients will undergo the surgical implantation of a Tenckhoff peritoneal dialysis catheter before study start. After the successful insertion of the Tenckhoff catheter, study patients will enter a run-in phase, where their residual renal function, volume, hemodynamic and cardiac status during HD will be assessed. During the following weeks (intervention weeks 1, 2, 3), study patients will receive in-center iPUF intervention, consisting of peritoneal infusate instillation of a 10% dextrose solution via a Tenckhoff catheter, immediately after the first two HD sessions of the week (Monday, Wednesday); the infusate will be dwelling in the study patient's peritoneal cavity for 2 hours, at the end of which the solution will be drained and the patient sent home. Study patients will be monitored during infusate administration and for the first four hours thereafter. The study intervention will be discontinued at the beginning of week 5 (Wash-out); during week 5 and the first HD session of week 6, study patients will be monitored to observe potential residual effects of the iPUF intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis, Hemodialysis, Peritoneal Dialysis, Nonosmotic Sodium Storage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interdialytic peritoneal ultrafiltration
Arm Type
Experimental
Arm Description
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks
Intervention Type
Combination Product
Intervention Name(s)
Interdialytic peritoneal ultrafiltration with 10% dextrose solution
Intervention Description
Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks
Primary Outcome Measure Information:
Title
Skin sodium concentration
Description
Skin sodium concentration at the end of week 4 as measured by sodium-23 magnetic resonance imaging of the leg.
Time Frame
End of week 4
Title
Adverse events
Description
Completion of the iPUF treatment without adverse events
Time Frame
iPUF interventions on Week 2, 3 and 4
Secondary Outcome Measure Information:
Title
Interdialytic weight gain
Description
Difference in interdialytic weight gain at run-in week vs end of intervention, vs wash-out
Time Frame
week 1 vs 4, week 1 vs 5-6
Title
Total weekly sodium removal with interdialytic peritoneal ultrafiltration
Description
Total weekly sodium removal with peritoneal dialysis in intervention weeks
Time Frame
week 2, 3, 4
Title
Total volume of fluid removed with interdialytic peritoneal ultrafiltration
Description
Total volume of fluid removed with peritoneal dialysis in intervention weeks
Time Frame
week 2, 3, 4
Title
Home blood pressure
Description
Changes in home blood pressure at baseline vs end of intervention and vs washout
Time Frame
week 1 vs week 4, week 1 vs 5-6
Title
Mean intradialytic hemodynamics
Description
Changes in mean intradialytic hemodynamic monitor parameters, as measured with Finometer and CVInsight
Time Frame
week 1 vs 4, week 1 vs 6
Title
Regional wall motion abnormalities
Description
Changes in Regional Wall Motion Abnormalities (echocardiography) at peak-stress hemodialysis
Time Frame
week 1 vs 4, week 1 vs 6
Title
Symptoms
Description
Changes in symptoms as measured with the London Evaluation of Illness questionnaire
Time Frame
week 1 vs 4, week 1 vs 6
Title
Infusion pain
Description
Infusion pain as measured with 0-10 visual analog scale
Time Frame
Through study completion, average of all study treatments
Title
Changes in serum sodium
Description
Post-iPUF change in serum sodium
Time Frame
Through study completion, average of all study treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Jarosz, MMASc
Phone
519-685-8500
Ext
56550
Email
patricia.jarosz@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher W. McIntyre, MD, PhD
Organizational Affiliation
Lawson Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Jarosz, MMASc
Phone
519.685.8500
Ext
56550
Email
Patricia.Jarosz@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23493384
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.
Results Reference
background
PubMed Identifier
29793962
Citation
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.
Results Reference
background
PubMed Identifier
9831090
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.
Results Reference
background
PubMed Identifier
12888617
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.
Results Reference
background
PubMed Identifier
22146510
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.
Results Reference
background
PubMed Identifier
19412173
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.
Results Reference
background
PubMed Identifier
29661837
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.
Results Reference
background
PubMed Identifier
32252091
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.
Results Reference
background
PubMed Identifier
30665570
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.
Results Reference
background
PubMed Identifier
25100048
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.
Results Reference
background
PubMed Identifier
21175831
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.
Results Reference
background
PubMed Identifier
27169576
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.
Results Reference
background
PubMed Identifier
16623416
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.
Results Reference
background
PubMed Identifier
15559484
Citation
McIntyre CW. Bimodal dialysis: an integrated approach to renal replacement therapy. Perit Dial Int. 2004 Nov-Dec;24(6):547-53.
Results Reference
background
PubMed Identifier
32063198
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.
Results Reference
background
PubMed Identifier
31851981
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.
Results Reference
background
PubMed Identifier
28185405
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.
Results Reference
background
PubMed Identifier
31910658
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.
Results Reference
background
PubMed Identifier
11572901
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.
Results Reference
background
PubMed Identifier
28360368
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.
Results Reference
background
PubMed Identifier
12897121
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.
Results Reference
background

Learn more about this trial

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

We'll reach out to this number within 24 hrs