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Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose

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.


Condition Intervention Phase
Hemodialysis Fluid Allergy
Device: Dry weight adjustment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypervolemia and Treatment Guided by Bioimpedance in End Stage Renal Disease Patients in Zonguldak (Prospective Study)

Further study details as provided by Zonguldak Karaelmas University:

Primary Outcome Measures:
  • Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique [ Time Frame: within 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 550
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dry weight adjustment according to BCM results
Other Names:
  • Group 1: BCM Adjusted Group
  • Group 2: Classical Group
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
Dry weight adjustment according to BCM results
Other Names:
  • Group 1: BCM Adjusted Group
  • Group 2: Classical Group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468363

Locations
Turkey
Devrek Devlet Hastanesi
Zonguldak, Devrek, Turkey
Ereğlı Burcu Koç Diyaliz Merkezi
Zonguldak, Ereğli, Turkey
Ereğlı Can Diyaliz Merkezi
Zonguldak, Ereğli, Turkey
Ereğli Devlet Hastanesi Diyaliz Merkezi
Zonguldak, Ereğli, Turkey
Atatürk Devlet Hastanesi Diyaliz Merkezi
Zonguldak, Turkey
Devrek Can Diyaliz Merkezi
Zonguldak, Turkey
ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi
Zonguldak, Turkey
Zonguldak Can Diyaliz Merkezi
Zonguldak, Turkey
Çaycuma Devlet Hastanesi Diyaliz Merkezi
Zonguldak, Turkey
Çaycuma Can Diyaliz Merkezi
Zonguldak, Çaycuma, Turkey
Sponsors and Collaborators
Zonguldak Karaelmas University
Investigators
Principal Investigator: Ender Hur, M.D ZKU Nephrology Department