RECRUITING

Trial of Variable Dialysate Bicarbonate

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-24
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05814146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * prevalent end-stage renal disease, on maintenance HD \> 90 days
  2. * age ≥ 18 years old
  3. * thrice weekly HD
  1. * hemoglobin \< 8.0 g/dL
  2. * pregnancy
  3. * any physical, mental or medical condition which limited the ability to provide written informed consent

Contacts and Locations

Study Contact

Katherine S Ravi, MD, MPH
CONTACT
(617) 732-6383
ksravi@bwh.harvard.edu

Principal Investigator

Katherine S Ravi, MD, MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Katherine S Ravi, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-24
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2023-08-24
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Peri-dialytic Cardiac Rhythms
  • Intradialytic Hypotension
  • Electrolyte Changes
  • pH Changes
  • Adverse Symptoms