AzTrials
AzTrials

HypertensionNCT00067665

Hypertension in Hemodialysis

A study testing Ultrafiltration in people with Hypertension and Left Ventricular Hypertrophy, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Left Ventricular Hypertrophy
What is being tested?
Ultrafiltration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Aug 2003to Jun 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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 Patients with well-controlled hypertension, on anti-hypertensive therapy will have blood pressure medications withdrawn until they become hypertensive as assessed by 44-hour interdialytic ambulatory blood pressure recording.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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Indiana University Affiliated Dialysis Unit

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

Being tested
Ultrafiltration
Keywords
hemodialysis
Medical subject headings
Hypertension, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT00067665
Study groupRoleWhat they receive
1No interventionControl group of 50 patients where dry weight is not changed.
2ExperimentalAll 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.
Receives: Other: Ultrafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 0, 4, 8 wks

Secondary outcomes (1)

  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)

    Measured: 0, 4, 8 wks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067665
Sponsor's protocol ID
(DK62030)
Other IDs
R01DK062030
Status last verified
Jan 2011
First submitted
25 Aug 2003
Last updated
28 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21330484

  • 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.

    PubMed 20167684

  • 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.

    PubMed 20038754

  • 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.

    PubMed 19528362

  • 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.

    PubMed 19515473

  • 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.

    PubMed 19153263

Questions about this trial

What is this clinical trial studying?

A study testing Ultrafiltration in people with Hypertension and Left Ventricular Hypertrophy, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00067665, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in