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Hypertension in Hemodialysis

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ClinicalTrials.gov Identifier: NCT00067665
Recruitment Status : Completed
First Posted : August 27, 2003
Last Update Posted : March 28, 2011
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Indiana University

Tracking Information
First Submitted Date  ICMJE August 25, 2003
First Posted Date  ICMJE August 27, 2003
Last Update Posted Date March 28, 2011
Study Start Date  ICMJE August 2003
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
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 [ Time Frame: 0, 4, 8 wks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
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) [ Time Frame: 0, 4, 8 wks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypertension in Hemodialysis
Official Title  ICMJE Hypertension in Hemodialysis
Brief Summary How high blood pressure in hemodialysis patients should be diagnosed and treated using medications or without medications is the purpose of this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Left Ventricular Hypertrophy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: 1
    Control group of 50 patients where dry weight is not changed.
  • Experimental: 2
    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.
    Intervention: Other: Ultrafiltration
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 23, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE - 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00067665
Other Study ID Numbers  ICMJE (DK62030)
R01DK062030 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rajiv Agarwal, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE Not Provided
PRS Account Indiana University
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP