Trial of Variable Dialysate Bicarbonate

Intradialytic Hypotension Clinical Trial

Official title:

Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814146
• Other study ID #: 2022P002944
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: Katherine S Ravi, MD, MPH
• Phone: (617) 732-6383
• Email: ksravi[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death. It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions. This study aims to assess the effects of lower (30 mEq/L) versus higher (35 mEq/L) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital. The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: October 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• prevalent end-stage renal disease, on maintenance HD > 90 days
• age = 18 years old
• thrice weekly HD

Exclusion Criteria:

• hemoglobin < 8.0 g/dL
• pregnancy
• any physical, mental or medical condition which limited the ability to provide written informed consent

Related Conditions & MeSH terms

• Hypotension
• Intradialytic Hypotension

Intervention

Drug:
• Dialysate bicarbonate concentration
Assess how a lower dialysate bicarbonate affects: QTc duration during and between hemodialysis sessions PVC burden during and between hemodialysis sessions Clinically significant arrhythmia during and between hemodialysis sessions Intradialytic hypotension Adverse symptoms during hemodialysis sessions

Device:
• Dialysate bicarbonate concentration - telemetry monitoring
Patients will be monitored with telemetry on both arms of the trial.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PVC frequency	Holter monitors will be used to assess PVC frequency during HD sessions and in the subsequent inter-HD period. The investigators will also assess PVC coupling interval variability in these time intervals.	PVCs/hour will be recorded during HD sessions and for ~44-68 hours from the end of the hemodialysis session until the subsequent hemodialysis session.
Other	Clinically significant arrhythmia	As described in the Monitoring in Dialysis (MiD) study, clinically significant arrhythmia is defined as: sustained ventricular tachycardia, bradycardia, asystole and symptomatic arrhythmias.	Clinically significant arrhythmia will be assessed during hemodialysis sessions and in the subsequent inter-hemodialysis period (until the subsequent hemodialysis session, up to 68 hours).
Other	Intradialytic hypotension	Intradialytic hypotension will be defined as systolic blood pressure <90 during hemodialysis. The investigators will also conduct sensitivity analyses using alternative definitions of intradialytic hypotension (e.g. nadir intra-hemodialysis systolic blood pressure <90mmHg if pre-hemodialysis systolic blood pressure is <160mmHg or nadir intra-hemodialysis systolic blood pressure <100mmHg if pre-hemodialysis systolic blood pressure is =160mmHg). Additionally, the investigators will examine the overall mean decline in systolic blood pressure during hemodialysis as a continuous outcome (intra-hemodialysis systolic blood pressure decline=pre-hemodialysis systolic blood pressure minus nadir systolic blood pressure during hemodialysis).	Blood pressures will be measured every 15 minutes during HD sessions.
Other	Electrolytes	Samples are collected from the hemodialysis circuit (no extra blood sticks) for freezing for comprehensive metabolic panels.	Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
Other	pH	Samples are collected from the hemodialysis circuit (no extra blood sticks) for immediate blood gas analysis.	Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
Other	Ionized calcium level	Samples are collected from the hemodialysis circuit (no extra blood sticks) for immediate evaluation of ionized calcium level.	Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).
Other	Adverse symptoms	The investigators will administer the modified Edmonton Symptom Assessment System (mESAS). The mESAS measures patient-reported severity of pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath and pruritus using a 0-10 score (anchored by "No" at 0 and "Severe" at 10). A validated Spanish version is available and a translator will help to administer the questionnaire as well as with all communication with patients in any language other than English.	Questionnaires will be administered during the last 10 minutes of hemodialysis sessions.
Primary	QTc prolongation	QTc prolongation, calculated as post-HD (just as HD finishing, generally 4 hours from start of HD session) minus pre-HD QTc duration, will be obtained via Holter monitoring.	During hemodialysis procedure (during dialysate administration)