Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05814146
Other study ID # 2022P002944
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT02264522 - Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration N/A
Recruiting NCT02583802 - The Clinical Study of Improving the Thirst and Hypotension of Hemodialysis Patients Phase 2/Phase 3
Terminated NCT00576524 - Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis Phase 2
Not yet recruiting NCT05517993 - Effect of Gui-Lu-Er-Xian-Jiao-Wan on Intradialytic Hypotension Phase 2/Phase 3
Completed NCT04180514 - Applying Pulse Wave Analysis to Predict Intradialytic Hypotension
Completed NCT03916861 - BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy N/A
Completed NCT00257504 - Central Blood Volume in Hypotensive Dialysis Patients N/A
Enrolling by invitation NCT03080441 - Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention Phase 4
Active, not recruiting NCT05905692 - Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis Phase 3
Completed NCT03057392 - Head Out Water Immersion for Hemodynamic Stability During Dialysis N/A
Recruiting NCT02210377 - A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension Phase 2
Recruiting NCT05270759 - Non-invasive Assessment to Predict Tolerance to Fluid Removal on Intermittent Kidney Replacement Therapy
Completed NCT01988181 - Adjusting Fluid Removal Based on Blood Volume in Hemodialysis: A Randomized Study N/A
Completed NCT02159625 - Abdominal Compression Elastic Support (ACES) N/A
Completed NCT06279156 - Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension N/A
Completed NCT03249532 - Effect of Dialysis Techniques on Blood Pressure and Cardiac Function During Dialysis N/A
Completed NCT03504943 - Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension N/A
Completed NCT02719223 - The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension N/A
Recruiting NCT04163614 - Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients N/A
Recruiting NCT05936710 - Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate N/A