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Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00237783
Recruitment Status : Terminated (Unable to recruit enough subjects)
First Posted : October 12, 2005
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE October 7, 2005
First Posted Date  ICMJE October 12, 2005
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE October 2005
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
Intradialytic BP change [ Time Frame: from study onset through intervention, week 7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
Intradialytic BP change
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2016)
  • Intradialytic changes in cardiac output and peripheral vascular resistance [ Time Frame: from study onset through intervention, week 7 ]
  • Interdialytic weight gain change [ Time Frame: from study onset through intervention, week 7 ]
  • Thirst scores [ Time Frame: from study onset through intervention, week 7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2005)
  • Intradialytic changes in cardiac output and peripheral vascular resistance
  • Interdialytic weight gain change
  • Thirst scores
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic Hypotension
Official Title  ICMJE Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients
Brief Summary Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.
Detailed Description Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control. In this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 2 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemodialysis
  • Hypotension
Intervention  ICMJE
  • Drug: dialysate sodium (140 mmol/L)
  • Drug: individualized dialysate sodium
    individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
Study Arms  ICMJE
  • Active Comparator: standard dialysate sodium (140 mmol/L)
    dialysate sodium (140 mmol/L)
    Intervention: Drug: dialysate sodium (140 mmol/L)
  • Experimental: individualized dialysate sodium
    individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)
    Intervention: Drug: individualized dialysate sodium
Publications * de Paula FM, Peixoto AJ, Pinto LV, Dorigo D, Patricio PJ, Santos SF. Clinical consequences of an individualized dialysate sodium prescription in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1232-8. Erratum in: Kidney Int. 2004 Nov;66(5):2108.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
4
Original Enrollment  ICMJE
 (submitted: October 7, 2005)
7
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hemodialysis patients with intradialytic hypotension

Exclusion Criteria:

  • Atrial fibrillation
  • Bilateral upper extremity arteriovenous access
  • Average plasma sodium >139
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00237783
Other Study ID Numbers  ICMJE AP0008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aldo J Peixoto, MD Yale University and VA Connecitcut Healthcare System
PRS Account Yale University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP