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Hemodialysis Fluid AllergyPhase 4NCT01468363

Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)

A Phase 4 study testing Dry weight adjustment in people with Hemodialysis Fluid Allergy, run by Zonguldak Bulent Ecevit University at 10 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There is no easily applicable method to determine extra cellular volume and consequently estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect methods. Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hemodialysis Fluid Allergy
What is being tested?
Dry weight adjustment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
10 sitesTurkey (Türkiye)
Study dates
Nov 2011to Nov 2012
Phase
Phase 4
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age older than 18-year,
  • Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
  • Willingness to participate in the study with a written informed consent.

Who cannot join

  • Presence of a cardiac stent, pacemaker or defibrillator ,
  • Artificial joints, pin or amputation
  • Permanent or temporary catheters (may affect BCM measurement),
  • Beeing scheduled for living donor renal transplantation,
  • Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
  • Pregnancy or lactating,
  • Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,
  • Mental incompetence.

Trial locations and contacts

10 sites in 1 country.

Gursel Yildiz, MD contact

00905055422909

drgursel@yahoo.com

10 sites in 1 country

Turkey (Türkiye)10 sites, 10 recruiting
  • Devrek Devlet Hastanesi

    Zonguldak, Devrek

    Gursel Yilidiz, M.D

    Gursel Yildiz, M.D

    Recruiting
  • Ereğli Devlet Hastanesi Diyaliz Merkezi

    Zonguldak, Ereğli

    Ender Hur

    Ender Hur, M.D

    Recruiting
  • Ereğlı Burcu Koç Diyaliz Merkezi

    Zonguldak, Ereğli

    Ender Hur, 00905322462487, hurender@hotmail.com

    Ender Hur, M.D

    Recruiting
  • Ereğlı Can Diyaliz Merkezi

    Zonguldak, Ereğli

    Ender Hur, M.D, 00905322462487, hurender@hotmail.com

    Ender Hur, M.D

    Recruiting
  • Atatürk Devlet Hastanesi Diyaliz Merkezi

    Zonguldak

    Gursel Yildiz, M.D, drgursel@yahoo.com

    Gursel Yildiz, M.D

    Recruiting
  • Devrek Can Diyaliz Merkezi

    Zonguldak

    Gursel Yilidiz, 00905055422909, drgursel@yahoo.com

    Gursel Yildiz, M.D

    Recruiting
  • ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi

    Zonguldak

    Kemal Magden, MD

    Utku Soyaltin, MD

    Recruiting
  • Zonguldak Can Diyaliz Merkezi

    Zonguldak

    Ender Hur, M.D, 00905322462487, hurender@hotmail.com

    Ender Hur, M.D

    Recruiting
  • Çaycuma Devlet Hastanesi Diyaliz Merkezi

    Zonguldak

    Gursel Yilidiz

    Gursel Yildiz, M.D

    Recruiting
  • Çaycuma Can Diyaliz Merkezi

    Zonguldak, Çaycuma

    Gursel Yilidiz, M.D, 005055422909, drgursel@yahoo.com

    Gursel Yilidiz, M.D

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Hypervolemia and Treatment Guided by Bioimpedance in End Stage Renal Disease Patients in Zonguldak (Prospective Study)

There is no easily applicable method to determine extra cellular volume and consequently estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect methods.

Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available. This non-invasive, cheap easily repeatable method has the potential to improve dialysis outcome in the majority of patients all over the world, The aim of the present project is to assess the feasibility of volume control by using a BİS device.

Read the detailed description

The excessive mortality of dialysis patients, particularly from cardiovascular events, is undoubtedly related for a large part to hypertension and cardiac damage(1). Most studies reveal that hypertension persists despite antihypertensive drugs. Some authors (Parfrey) have used the term ''natural history'' of heart disease in dialysis, suggesting that deterioration is inevitably linked to that procedure (2).

In sharp contrast, other studies (Charra, Özkahya)(3,4) have shown that a strict volume control strategy decreases blood pressure (BP) without drugs, and prolongs survival. This suggests that volume control is insufficient in most dialysis centers, despite the fact that treating physicians may consider that ''Dry Weight'' (DW) of their patients has been reached. In fact, there is no easily applicable method to determine extra cellular volume and consequently estimate DW. Thus DW has to be clinically defined by ''trial and error'' and several indirect methods.

Recently, devices to measure DW by Bioimpedance spectroscopy (BİS) have become available. This non-invasive, cheap easily repeatable method has the potential to improve dialysis outcome in the majority of patients all over the world, The aim of the present project is to assess the feasibility of volume control by using a BİS device and compare the results with the conventional ways of treatment.

Conventional ways to estimate DW (5)Intradialytic hypotension continues to be a leading problem, especially in the elderly and cardiovascularly compromised patient. This predominance can be explained by the fact that structural and functional abnormalities of the heart and blood vessels increase the sensitivity of the patient to changes in fluid status. It does not only cause discomfort, but also increases mortality. In a recent study, a low post-dialytic blood pressure was associated with a significantly increased risk for mortality . Therefore prevention of intradialytic hypotension, remains an important challenge to the dialysis physician.

The occurrence of hypotension during ultrafiltration (UF) necessitates termination of the UF procedure and is commonly considered as a sign that DW has been reached. However, although intradialytic hypotension is commonly considered to be a sign of hypovolemia, this is not always correct, because too rapid removal of large amounts of fluid within a few hours causes a temporary state of disequilibrium. It has been shown that achievement of DW by volume control in fact decreases the number of hypotensive episodes (5) Therefore, there is a need for objective methods to estimate the body fluid volumesThis prospective, randomized, controlled study aims to evaluate the usefulness of the new BCM device as a method to improve volume control dialysis patients and compare the results with those obtained by conventional volume control modalities. To our knowledge such an investigation has not been done elsewhere.

The investigators believe that the proposed study will produce powerful evidence to convince the nephrological society of the need for strict volume control strategy by using new device BCM in hemodialysis patients. The expected data may change routine practice causing achievement of normal blood pressure level without using anti-hypertensive medication.

Being tested
Dry weight adjustment
Keywords
Dry weight, Body composition monitor, Hemodialysis, Zonguldak

What participants receive

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

  • Dry weight adjustmentDevice

    Also called Group 1: BCM Adjusted Group, Group 2: Classical Group

    Dry weight adjustment according to BCM results

Study groups in NCT01468363
Study groupRoleWhat they receive
Group 1Active comparator"Overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH) in order to determine dry weight as needed before a dialysis session. 1. If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure. 2. If OH is negative value , we will not change dry weight.
Receives: Device: Dry weight adjustment
Group 2No interventionBCM results obtained at the beginning and 12th months will not be given to the treating physicians. Dry weight estimation will be guided by clinical findings, telecardiography, and echocardiography as used to be.
Receives: Device: Dry weight adjustment

What is being measured

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

  1. Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique

    Measured: within 1 year

Secondary outcomes (1)
  1. Achievement of normal blood pressure level without using anti-hypertensive medication

    Achievement of normal blood pressure level without using anti-hypertensive medication Changes in post-dialysis body weight Hematocrit and related rHu-EPO doses Serum levels of albumin and Hs-CRP

    Measured: within 1 year

Timeline

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

  1. First posted9 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2012 (estimated)
  4. Study completionNov 2012 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01468363
Sponsor's protocol ID
ZKU 2011-77-21/06
Status last verified
Nov 2011
First submitted
5 Nov 2011
Last updated
10 Nov 2011
Results posted
No
Data monitoring committee
No

Publications

  • Akcicek F, Dilber S, Ozgen G, Ok E, Akalin E, Atabay G, Basci A, Guclu A, Dorhout Mees EJ. Spontaneous perirenal hematoma due to periarteritis nodosa. Nephron. 1994;68(3):396. doi: 10.1159/000188413. No abstract available.

    PubMed 7838273
  • Coker A, Ok E, Tokat Y, Hoscoskun C, Kaplan H, Yararbas O. Evaluation of patients transplanted in countries other than Turkey. Transplant Proc. 1994 Aug;26(4):2455-6. No abstract available.

    PubMed 8066803
  • Ok E, Akcicek F, Toz H, Kursat S, Tobu M, Basci A, Mees EJ. Comparison of the effects of enalapril and theophylline on polycythemia after renal transplantation. Transplantation. 1995 Jun 15;59(11):1623-6.

    PubMed 7778179
  • Ok E, Akcicek F, Coker A, Tombuloglu M, Toz H, Tokat Y, Cirit M, Tobu M, Onder G, Basci A. Alloimmune haemolytic anaemia after renal transplantation. Nephrol Dial Transplant. 1995;10(3):404-5. No abstract available.

    PubMed 7792041
  • Ok E, Akcicek F, Dorhout Mees EJ, Basci A, Mir S, Kursat S, Unsal A. Malignant hypertension in a haemodialysis patient treated by ultrafiltration. Nephrol Dial Transplant. 1995 Nov;10(11):2124-5. No abstract available.

    PubMed 8643182

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dry weight adjustment in people with Hemodialysis Fluid Allergy, run by Zonguldak Bulent Ecevit University at 10 sites in Turkey (Türkiye).

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

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Turkey (Türkiye). 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Ender Hur, MD (00903722612223, hurender@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique (time frame: within 1 year). 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 NCT01468363, which also lists 5 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 10 Nov 2011.

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