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N/A Completed N=139 Randomized Quadruple-blind Treatment

Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Intra-dialytic Hypotension
Source: ClinicalTrials.gov NCT02145260 ↗
Enrolled (actual)
139
Serious AEs
1.4%
Results posted
Oct 2022
Primary outcomePrimary: Change in Intra-dialytic Decline in Systolic Blood Pressure — 26; 23 mm Hg

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Intra-dialytic Decline in Systolic Blood Pressure		 26; 23 —
SECONDARY
Change in Pre-dialysis High-sensitivity Troponin I		 — —

Eligibility 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02145260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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