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NCT Number: NCT02145260

Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

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.

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Key information

Conditions

Intra-dialytic Hypotension Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)

Drug

A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)

Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

Drug

A higher dialysate sodium will be used in the experimental arm (142 mmol/L)

Primary outcomes

  1. Change in 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

    Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.

Secondary outcomes

  1. 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

    Cardiac injury biomarkers

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
May 22, 2014
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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