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Completed

NCT Number: NCT02098356

Comparison of High Versus Low Bicarbonate Hemodialysis

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.

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Key information

Conditions

Chronic Kidney Disease Acid-Base Imbalance Acidosis Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Acidosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18
  • Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months

Exclusion criteria

  • Use of oral alkali within the previous month
  • Hospitalization within the previous month
  • Inability to provide written informed consent
  • Plans for kidney transplant in the next 2 months
  • Planned change in phosphate binder therapy within the next month
  • Pregnancy, or planned pregnancy in the next 2 months

Treatment and study plan

Low Bicarbonate

Other

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Primary outcomes

  1. Pre-dialysis serum bicarbonate

    Time frame: 5 weeks

    Change in predialysis bicarbonate

Secondary outcomes

  1. serum beta-hydroxybutyrate

    Time frame: 5 weeks

    Change in beta-hydroxybutyrate during dialysis

  2. beta-hydroxybutyrate clearance

    Time frame: 5 weeks

    Change in clearance between different dialysates

  3. interleukin-6

    Time frame: 5 weeks

    Change during dialysis

  4. serum free fatty acids

    Time frame: 5 weeks

    Change during dialysis

  5. Time to recover from dialysis

    Time frame: 5 weeks

    Change between dialysates

  6. Dialysis symptom questionnaire

    Time frame: 5 weeks

    Change between dialysates

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Official study title

Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Jul 5, 2019

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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