Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Finnian McCausland, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02145260
First received: May 13, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.

Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular and intra-cellular compartments, promoting trans-cellular fluid movement and resultant hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may ameliorate excess SBP decline during HD.

This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L) dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on intra-dialytic blood pressure and biomarkers of cardiac ischemia.

The investigators will randomly assign subjects to higher versus lower DNa during their hospital stay, up to a maximum of six HD sessions.


Condition Intervention
Intra-dialytic Hypotension
Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Magnitude of intra-dialytic decline in systolic blood pressure [ Time Frame: Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in pre-dialysis high-sensitivity troponin I [ Time Frame: The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lower dialysate sodium
Dialysate sodium concentration of 138 mmol/L
Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
Experimental: Higher dialysate sodium
Dialysate sodium concentration of 142 mmol/L
Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
A higher dialysate sodium will be used in the experimental arm (142 mmol/L)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HD (>90 days)
  • Age ≥18y
  • Informed consent
  • First admission during study period.

Exclusion Criteria:

  • Use of pressors
  • Pre-dialysis serum sodium <=128mmol/L or > 145 mmol/L
  • Pre-dialysis SBP >180 mmHg
  • Intensive care stay earlier in admission
  • Expected length of stay <24 hours (e.g. admission for HD access procedure)
  • Acute coronary syndrome within seven days
  • Acute stroke
  • Institutionalized individuals
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02145260

Contacts
Contact: Finnian Mc Causland, MB, MMSc fmccausland@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Finnian Mc Causland, MB, MMSc       fmccausland@partners.org   
Sub-Investigator: Sushrut Waikar, MD, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Finnian Mc Causland, MB, MMSc Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Finnian McCausland, Instructor in Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02145260     History of Changes
Other Study ID Numbers: 2014P000629
Study First Received: May 13, 2014
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Hemodialysis
Hypotension
Hospitalization

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014