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Effect of Dialysis Techniques on Blood Pressure and Cardiac Function During Dialysis (HOLLANT)

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ClinicalTrials.gov Identifier: NCT03249532
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : February 25, 2019
Sponsor:
Collaborators:
Niercentrum aan de Amstel, Amstelveen, Netherlands
B.Braun Avitum AG
Information provided by (Responsible Party):
M.P.C. Grooteman, VU University Medical Center

Brief Summary:
Online hemodiafiltration confers a reduced mortality risk. However, it is not clear why HDF improved survival. To gain more insight in this issue, the effect of 4 dialysis techniques (differing in dialysate temperature and the absence/presence of convective clearance) on intradialytic hemodynamic stability and cardiac function will be investigated in a prospective cross over trial.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Hemodialysis Hemodiafiltration Intradialytic Hypotension Diastolic Dysfunction Device: standard hemodialysis Device: cool hemodialysis Device: low volume hemodiafiltration Device: high volume hemodiafiltration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: prospective, cross over, randomized order
Masking: Single (Outcomes Assessor)
Masking Description: treatment period will not be available to the assessors of secondary outcomes.
Primary Purpose: Treatment
Official Title: Effect of High-volume Online hemodiafiLtration on Intra-diaLytic hemodynAmic (iN)sTability and Cardiac Function in Chronic Hemodialysis Patients (the HOLLANT Study)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: standard hemodialysis
prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 0 Liters (L)
Device: cool hemodialysis
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable

Device: low volume hemodiafiltration
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L

Device: high volume hemodiafiltration
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L

Active Comparator: cool hemodialysis
prescription of dialysate temperature: 35.5 degrees celsius prescription of convection volume: 0 L
Device: standard hemodialysis
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable

Device: low volume hemodiafiltration
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L

Device: high volume hemodiafiltration
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L

Active Comparator: low volume hemodiafiltration
prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L
Device: standard hemodialysis
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable

Device: cool hemodialysis
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable

Device: high volume hemodiafiltration
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L

Active Comparator: high volume hemodiafiltration
prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L
Device: standard hemodialysis
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable

Device: cool hemodialysis
hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable

Device: low volume hemodiafiltration
hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L




Primary Outcome Measures :
  1. intradialytic hypotension [ Time Frame: up to 4 hours (= one dialysis treatment); assessed during 3 treatments on each modality ]
    nadir in systolic blood pressure (SBP) of 90 mmHg for patient with predialysis SBP <160mmHg and a nadir of 100 mmHg for patients with predialysis SBP ≥160 mmHg during treatment (blood pressure will be measured before and every 15 minutes after the start of dialysis during the treatment)


Secondary Outcome Measures :
  1. diastolic dysfunction during treatment [ Time Frame: up to 4 hours (= one dialysis treatment); assessed during 1 treatment on each modality ]
    speckle tracking echocardiography will be performed before, after 60 minutes of dialysis and after and after 3,5 hours


Other Outcome Measures:
  1. systolic blood pressure [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality ]
    change in systolic blood pressure (mmHg)

  2. diastolic blood pressure [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality ]
    change in diastolic blood pressure (mmHg)

  3. mean arterial blood pressure [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality ]
    change in mean arterial blood pressure (mmHg)

  4. pulse pressure [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality ]
    change in pulse pressure (systolic - diastolic blood pressure; mmHg)

  5. beat-to-beat blood pressure [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    change in beat-to-beat blood pressure (finger cuff; mmHg)

  6. heart rate [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    change in heart rate (finger cuff assessment)

  7. stroke volume [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    change in stroke volume (finger cuff assessment)

  8. cardiac output [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    change in cardiac output (finger cuff assessment)

  9. total peripheral resistance [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    change in total peripheral resistance (finger cuff assessment)

  10. number of sessions with reached target dry weight [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 3 treatments on each modality ]
    number of sessions with reached target dry weight (kg)

  11. relative blood volume [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 2 treatments on each modality ]
    relative blood volume (%) during dialysis treatment

  12. oxygen saturation [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 2 treatments on each modality ]
    oxygen saturation in the arterial line of the extracorporeal system (%) during dialysis treatment; patients with central venous catheters and fistulas/grafts will be analyzed separately

  13. oxygen partial pressure (pO2) [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    pO2 in the arterial line of the extracorporeal system (mmHg or kiloPascal [kPa], assessed by a point of care device) during dialysis treatment; patients with central venous catheters and fistulas/grafts will be analyzed separately

  14. change in creatine kinase (CK)-MB [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of cardiac damage, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  15. change in bacterial DNA in blood [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of gut ischemia, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  16. change in soluble CD14 [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of gut ischemia, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  17. change in extracellular vesicles (EVs) [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of endothelial damage, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  18. change in soluble intercellular adhesion molecule-1 (s-ICAM-1) [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of endothelial damage, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  19. change in high sensitivity C-reactive protein (hs-CRP) [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of inflammation, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  20. change in interleukin-6 (IL-6) [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of inflammation, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment

  21. change in fibroblast growth factor-23 (FGF-23) [ Time Frame: up to 4 hours(= one dialysis treatment); assessed during 1 treatment on each modality ]
    marker of inflammation/mineral bone disease, assessment in blood from arterial line of extracorporeal circuit, before and after dialysis treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • treatment with HD or HDF 3 x per week during at least 4 hours for at least 2 months
  • ability to understand study procedures
  • willingness to provide informed consent
  • single pool Kt/V urea (spKt/Vurea) ≥ 1.2
  • achievement of blood flow of ≥360 ml/min and/or convection volume of >23 Liter per treatment during the run-in phase

Exclusion Criteria:

  • - current age < 18 years
  • severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment
  • life expectancy < 3 months
  • participation in another clinical intervention trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249532


Contacts
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Contact: Muriel PC Grooteman, MD PhD + 31 20 444 2673 mpc.grooteman@vumc.nl

Locations
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Netherlands
St Antonius Ziekenhuis Not yet recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: E. A. van Gils, MD    +31 88 3203000      
Niercentrum aan de Amstel Completed
Amstelveen, Netherlands, 1186 AM
VUmc Recruiting
Amsterdam, Netherlands
Contact: Muriel PC Grooteman, MD PhD    +31 20 4442673    mpc.grooteman@vumc.nl   
Principal Investigator: Muriel PC Grooteman, MD PhD         
Sponsors and Collaborators
VU University Medical Center
Niercentrum aan de Amstel, Amstelveen, Netherlands
B.Braun Avitum AG
Investigators
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Principal Investigator: Muriel PC Grooteman, MD PhD VU University Medical Center
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Responsible Party: M.P.C. Grooteman, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03249532    
Other Study ID Numbers: ABR 61210
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Hypotension
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases