Blood Pressure In Dialysis Study

Study Team Principal Investigators Dana Miskulin, MD Andrew Levey, MD Study Coordinators Katie Knipscher Shana Haynes MRI Core Lab Raymond Kwong, MD Bobby Heydari, MD Henry Feng Sponsors NIH and DCI

Nationwide Study Tufts-NEMC (Dr. Miskulin) Satellite Healthcare University of Pittsburgh Medical Center (Dr. Unruh) DCC – Cleveland Clinic (Dr. Gassman) Tufts-NEMC (Dr. Miskulin) Satellite Healthcare (Dr. Schiller ) Medical University of South Carolina (Dr. Ploth ) University of New Mexico (Dr. Zager)

Why the BID Study is Important KDOQI recommends HD patients be treated to a pre-dialysis BP < 140/90 Zager et al (JASN 2005) show increased mortality in patients with BP < 140/90 Observational data are prone to bias High BP is a well-known cause of MI, stroke, CHF, and CV mortality For these reasons we do not know what BP we should be treating our patients to

Aim Aim To randomize hypertensive (pre-dialysis SBP > 155) patients to one of two BP goals: A “low” goal of 110-140/90 A “standard” goal of 155-165/90

Outcomes Outcomes Primary: Safety and feasibility of achieving and maintaining BP targets in the two arms Secondary: Change in LV mass

Study Timeline Recruit 33 patients from 4 dialysis units in the Boston area within 1 year DCI Somerville DCI Boston DCI Faulkner DaVita Boston Follow up period: 1 year

Blood Pressure Standard Dialysis Unit Blood Pressure Measurement (SDUBPM) will be taken before every dialysis session for every patient participating in the BID Study. 3 SDUBPMs and 1 pulse will be recorded using a LifeSource device on the form attached to the patient’s runsheet.

We Need Your Help Standardized Blood Pressure Prior to Every Treatment Attention to Documenting Intra-dialytic Complications

Procedure for SDUBPM Patient rests for 5 minutes in dialysis chair. Obtain patient’s LifeSource monitor from the ledge behind their regular dialysis chair. Take three readings, waiting 1 minute between each. Record all BPs on form attached to runsheet. Place form in the “BID” bin at front desk. Use the 3rd reading for the pre-dialysis BP on today’s runsheet.

Patients Must Rest for 5 Minutes To Ensure Accuracy of BPM We will provide digital timers to measure 5 minutes of rest, and 1 minute between each reading. We would like your input about what type of timer will work best for you.

Training and Certification We will review use of monitors individually

Blood Pressure Form UA 767

Charting It is important for us to be able to clearly read information about complications and BPs on the runsheet. If we need to find missing information or need clarification, we will need to come ask you.

Information We Will Need from Runsheets BPM every 30 minutes. All complications as well as comments on actions taken (or not taken) to resolve them. Ultrafiltration Plan A record of anything unusual that occurs during a treatment.

Complications of Interest Cramping Nausea/Vomiting Chest Pain Loss of Consciousness Shortness of Breath Seizure Intra or post dialysis systolic BP below 90 mmHg

Incentives We will have a drawing every other month for all staff who regularly complete study forms. The prize will be a $25 gift certificate (TBD). We welcome your suggestions for gift certificate locations.

Questions and Comments? BID Study Questions and Comments?