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Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Zonguldak Karaelmas University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ender Hur, Zonguldak Karaelmas University
ClinicalTrials.gov Identifier:
NCT01468363
First received: November 5, 2011
Last updated: November 9, 2011
Last verified: November 2011

November 5, 2011
November 9, 2011
November 2011
November 2012   (final data collection date for primary outcome measure)
Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique [ Time Frame: within 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01468363 on ClinicalTrials.gov Archive Site
Achievement of normal blood pressure level without using anti-hypertensive medication [ Time Frame: within 1 year ] [ Designated as safety issue: Yes ]
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
Same as current
Not Provided
Not Provided
 
Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemodialysis Fluid Allergy
Device: Dry weight adjustment
Dry weight adjustment according to BCM results
Other Names:
  • Group 1: BCM Adjusted Group
  • Group 2: Classical Group
  • 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.
    Intervention: 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.
    Intervention: Device: Dry weight adjustment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
November 2012
November 2012   (final data collection date for primary outcome measure)

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:

  • 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.
Both
18 Years to 80 Years
No
Contact: Ender Hur, MD 00903722612223 hurender@hotmail.com
Contact: Gursel Yildiz, MD 00905055422909 drgursel@yahoo.com
Turkey
 
NCT01468363
ZKU 2011-77-21/06
No
Ender Hur, Zonguldak Karaelmas University
Zonguldak Karaelmas University
Not Provided
Principal Investigator: Ender Hur, M.D ZKU Nephrology Department
Zonguldak Karaelmas University
November 2011

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