CClinicalTrials.gg
Status unknownNCT01468363Updated Nov 10, 2011

Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)

A Phase 4 interventional study of Dry weight adjustment in Hemodialysis Fluid Allergy, sponsored by Zonguldak Bulent Ecevit University. Status unknown at 10 sites in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-11-10.

Sponsored by Zonguldak Bulent Ecevit University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
550
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hemodialysis Fluid Allergy

Keywords

  • Dry weight
  • Body composition monitor
  • Hemodialysis
  • Zonguldak
03

In context

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
550 participants (estimated)

Study arms

  • Active comparator
    Group 1

    "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.

    Device: Dry weight adjustment

  • No intervention
    Group 2

    BCM 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.

    Device: Dry weight adjustment

Interventions

  • DeviceDry weight adjustment

    Dry weight adjustment according to BCM results

    Also known as: Group 1: BCM Adjusted Group, Group 2: Classical Group

06

What researchers measure

Primary outcomes

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

    Time frame: within 1 year

Secondary outcomes

  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

    Time frame: within 1 year

07

Study locations

10 of 10 sites recruiting
  • Devrek Devlet Hastanesi
    Zonguldak, Devrek, Turkey
    • Gursel Yilidiz, M.D · Contact
    • Gursel Yildiz, M.D · Sub investigator
    Recruiting
  • Ereğlı Burcu Koç Diyaliz Merkezi
    Zonguldak, Ereğli, Turkey
    • Ender Hur · Contact · hurender@hotmail.com · 00905322462487
    • Ender Hur, M.D · Principal investigator
    Recruiting
  • Ereğlı Can Diyaliz Merkezi
    Zonguldak, Ereğli, Turkey
    • Ender Hur, M.D · Contact · hurender@hotmail.com · 00905322462487
    • Ender Hur, M.D · Principal investigator
    Recruiting
  • Ereğli Devlet Hastanesi Diyaliz Merkezi
    Zonguldak, Ereğli, Turkey
    • Ender Hur · Contact
    • Ender Hur, M.D · Principal investigator
    Recruiting
  • Atatürk Devlet Hastanesi Diyaliz Merkezi
    Zonguldak, Turkey
    Recruiting
  • Devrek Can Diyaliz Merkezi
    Zonguldak, Turkey
    • Gursel Yilidiz · Contact · drgursel@yahoo.com · 00905055422909
    • Gursel Yildiz, M.D · Sub investigator
    Recruiting
  • ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi
    Zonguldak, Turkey
    • Kemal Magden, MD · Contact
    • Utku Soyaltin, MD · Contact
    • Ender Hur, M.D · Principal investigator
    • Kemal Magden, M.D · Sub investigator
    • Utku Soyaltin · Sub investigator
    Recruiting
  • Zonguldak Can Diyaliz Merkezi
    Zonguldak, Turkey
    • Ender Hur, M.D · Contact · hurender@hotmail.com · 00905322462487
    • Ender Hur, M.D · Principal investigator
    Recruiting
  • Çaycuma Devlet Hastanesi Diyaliz Merkezi
    Zonguldak, Turkey
    • Gursel Yilidiz · Contact
    • Gursel Yildiz, M.D · Sub investigator
    Recruiting
  • Çaycuma Can Diyaliz Merkezi
    Zonguldak, Çaycuma, Turkey
    • Gursel Yilidiz, M.D · Contact · drgursel@yahoo.com · 005055422909
    • Gursel Yilidiz, M.D · Sub investigator
    Recruiting
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01468363
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
Ender Hur (Medical Doctor, Specialist, Nephrology Department, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Nov 9, 2011
Start date
Nov 2011
Primary completion
Nov 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Nov 10, 2011

Study contacts

Ender Hur, MD
Contact
hurender@hotmail.com
00903722612223
Gursel Yildiz, MD
Contact
drgursel@yahoo.com
00905055422909
Ender Hur, M.D
principal investigator · ZKU Nephrology Department

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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