NCT00067665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 28, 2011

Status Verified

January 1, 2011

Enrollment Period

4.8 years

First QC Date

August 25, 2003

Last Update Submit

March 25, 2011

Conditions

HypertensionLeft Ventricular Hypertrophy

Keywords

hemodialysis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

NO INTERVENTION

Control group of 50 patients where dry weight is not changed.

2

EXPERIMENTAL

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.

Other: Ultrafiltration

Interventions

UltrafiltrationOTHER

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
\- 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Indiana University Affiliated Dialysis Unit

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

  • Agarwal R, Bouldin JM, Light RP, Garg A. Inferior vena cava diameter and left atrial diameter measure volume but not dry weight. Clin J Am Soc Nephrol. 2011 May;6(5):1066-72. doi: 10.2215/CJN.09321010. Epub 2011 Feb 17.

    PMID: 21330484DERIVED

  • Agarwal R, Light RP. Median intradialytic blood pressure can track changes evoked by probing dry-weight. Clin J Am Soc Nephrol. 2010 May;5(5):897-904. doi: 10.2215/CJN.08341109. Epub 2010 Feb 18.

    PMID: 20167684DERIVED

  • Sinha AD, Light RP, Agarwal R. Relative plasma volume monitoring during hemodialysis AIDS the assessment of dry weight. Hypertension. 2010 Feb;55(2):305-11. doi: 10.1161/HYPERTENSIONAHA.109.143974. Epub 2009 Dec 28.

    PMID: 20038754DERIVED

  • Agarwal R. Volume-associated ambulatory blood pressure patterns in hemodialysis patients. Hypertension. 2009 Aug;54(2):241-7. doi: 10.1161/HYPERTENSIONAHA.109.136366. Epub 2009 Jun 15.

    PMID: 19528362DERIVED

  • Agarwal R, Light RP. Chronobiology of arterial hypertension in hemodialysis patients: implications for home blood pressure monitoring. Am J Kidney Dis. 2009 Oct;54(4):693-701. doi: 10.1053/j.ajkd.2009.03.018. Epub 2009 Jun 10.

    PMID: 19515473DERIVED

  • Agarwal R, Alborzi P, Satyan S, Light RP. Dry-weight reduction in hypertensive hemodialysis patients (DRIP): a randomized, controlled trial. Hypertension. 2009 Mar;53(3):500-7. doi: 10.1161/HYPERTENSIONAHA.108.125674. Epub 2009 Jan 19.

    PMID: 19153263DERIVED

MeSH Terms

Conditions

HypertensionHypertrophy, Left Ventricular

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCardiomegalyHeart DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Extracorporeal CirculationSurgical Procedures, OperativeFiltrationChemistry Techniques, AnalyticalInvestigative TechniquesPhysical PhenomenaChemical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2003

First Posted

August 27, 2003

Study Start

August 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 28, 2011

Record last verified: 2011-01

Locations

US(1)