Hypertension in Hemodialysis

Hypertension Clinical Trial

Official title:

Hypertension in Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067665
• Other study ID #: (DK62030)
• Secondary ID: R01DK062030
• Status: Completed
• Phase: N/A
• First received: August 25, 2003
• Last updated: March 25, 2011
• Start date: August 2003
• Est. completion date: June 2008

Study information

• Verified date: January 2011
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

How high blood pressure in hemodialysis patients should be diagnosed and treated using medications or without medications is the purpose of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Adults with hypertension on hemodialysis Hypertensive, long-term (3 months or more) hemodialysis patients will be studied over a 6 hemodialysis baseline phase during which 44-hour interdialytic ambulatory BP will be performed and baseline symptoms collected. Patients with well-controlled hypertension, on anti-hypertensive therapy will have blood pressure medications withdrawn until they become hypertensive as assessed by 44-hour interdialytic ambulatory blood pressure recording. We will exclude patients who have had vascular event (stroke, myocardial infarction or limb ischemia requiring bypass) within previous six months, ambulatory BP >170 mm Hg systolic or >100 mm Hg diastolic, those who miss 2 or more hemodialysis treatments in the previous month, abuse street-drugs, require home oxygen, have symptomatic congestive heart failure or are morbidly obese (body mass index > 40 kg/m2).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Other:
• Ultrafiltration
All patients participating in the trial require evaluation of dry-weight at each dialysis visit for evaluation. An initial weight loss of 0.1kg/10 kg body-weight will be prescribed per dialysis. If ultrafiltration is not tolerated based on muscle cramps, need for excessive saline or symptomatic hypotension, the intensity of ultrafiltration will be reduced by 50%. If ultrafiltration is still not tolerated, the weight loss will be further reduced by 50%. If the patient cannot tolerate at least 0.2 kg incremental weight loss per dialysis, the patient will be said to be at goal dry-weight. Thus, by this protocol, all patients must experience symptoms of volume depletion to be at dry weight.

Locations

Country	Name	City	State
United States	Indiana University Affiliated Dialysis Unit	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome parameter will be systolic reduction in 44h-interdialytic ambulatory BP with ultrafiltration as compared to the control group by intention to treat analysis		0, 4, 8 wks	No
Secondary	Per protocol analysis of primary outcome with 1. weight loss as the covariate. 2. baseline left-atrial size and weight loss as covariates.3. Others: (Description restricted by space limitation)		0, 4, 8 wks	No