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Electrolyte Replacement

Lower dialysate bicarbonate for Intradialytic Hypotension

N/A

Recruiting

Led By Katherine S Ravi, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Thrice weekly HD

Prevalent end-stage renal disease, on maintenance HD for more than 90 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial aims to compare the effects of using lower versus higher dialysate bicarbonate levels in hemodialysis patients to see if it affects QTc prolongation and premature ventricular contractions. Participants

Who is the study for?

This trial is for adults over 18 with end-stage renal disease who have been on maintenance hemodialysis (HD) for more than 90 days, receiving treatments three times a week. It's not specified who can't join the trial.Check my eligibility

What is being tested?

The study tests the effects of two different bicarbonate levels in dialysate during HD sessions: lower (30 mEq/L) and higher (35 mEq/L). Patients are randomly assigned to one of these conditions during their hospital stay, up to six HD sessions or until discharge.See study design

What are the potential side effects?

Potential side effects may include changes in blood pressure, heart rhythm disturbances like QTc prolongation and PVCs, electrolyte imbalances, and other adverse effects related to hemodialysis treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I undergo hemodialysis three times a week.

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I have been on dialysis for over 90 days due to kidney failure.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

QTc prolongation

Other outcome measures

Adverse symptoms

Clinically significant arrhythmia

Electrolytes

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lower dialysate bicarbonateExperimental Treatment2 Interventions

A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).

Group II: Higher dialysate bicarbonateActive Control2 Interventions

A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,807 Total Patients Enrolled

2 Trials studying Intradialytic Hypotension

196 Patients Enrolled for Intradialytic Hypotension

Katherine S Ravi, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial open to individuals under 45 years old?

"Individuals aged 18 and above up to a limit of 120 years are eligible for participation in this research study."

Answered by AI

Is the enrollment for this research study currently open and accepting participants?

"As evidenced by the details on clinicaltrials.gov, this research project is currently in need of volunteers. The trial was initially published on August 24th, 2023 and last revised on February 23rd, 2024."

Answered by AI

What is the upper limit on the number of individuals participating in this medical study?

"Indeed, as per clinicaltrials.gov, this particular medical trial is actively seeking individuals to participate. The study was first listed on August 24th, 2023, and the most recent update was made on February 23rd, 2024. Enrollment of approximately 141 patients will take place at a single designated site."

Answered by AI

Is it possible for me to participate in this research project?

"The clinical study aims to enroll 141 individuals aged between 18 and 120 with intradialytic hypotension. Potential participants must also satisfy the subsequent conditions: prevalent end-stage renal disease, undergoing regular hemodialysis for over 90 days, at least 18 years old, and receiving thrice-weekly hemodialysis sessions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Variable Dialysate Bicarbonate

Katherine Scovner Ravi, MD, MPH 2023. "Trial of Variable Dialysate Bicarbonate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05814146.