Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Description

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.

Study Start Date

July 2014

Estimated Completion Date

July 2018

Interventions

  • Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
  • Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

Specialties

  • Family Medicine: Preventive/Nutrition
  • Nephrology: Dialysis,Hypertension
  • Nurse Practitioner: Nutrition

MeSH Terms

  • Hypotension
  • Intra-dialytic Hypotension
  • Lower dialysate sodium

Study ID

Brigham and Women's Hospital -- 2014P000629

Status

Unknown

Trial ID

NCT02145260

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

200

Sponsor

Brigham and Women's Hospital

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Finnian Mc Causland MB MMSc None fmccausland@partners.org

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