Hypervolemia in ESRD Patients in Zonguldak (Prospective Study)

November 9, 2011 updated by: Ender Hur, Zonguldak Bulent Ecevit University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Zonguldak, Turkey
        • Recruiting
        • Atatürk Devlet Hastanesi Diyaliz Merkezi
        • Sub-Investigator:
          • Gursel Yildiz, M.D
        • Contact:
      • Zonguldak, Turkey
        • Recruiting
        • Devrek Can Diyaliz Merkezi
        • Sub-Investigator:
          • Gursel Yildiz, M.D
        • Contact:
      • Zonguldak, Turkey
        • Recruiting
        • ZKU Uygulama ve Arş Hastanesi Diyaliz Merkezi
        • Principal Investigator:
          • Ender Hur, M.D
        • Contact:
          • Kemal Magden, MD
        • Contact:
          • Utku Soyaltin, MD
        • Sub-Investigator:
          • Kemal Magden, M.D
        • Sub-Investigator:
          • Utku Soyaltin
      • Zonguldak, Turkey
        • Recruiting
        • Zonguldak Can Diyaliz Merkezi
        • Principal Investigator:
          • Ender Hur, M.D
        • Contact:
      • Zonguldak, Turkey
        • Recruiting
        • Çaycuma Devlet Hastanesi Diyaliz Merkezi
        • Sub-Investigator:
          • Gursel Yildiz, M.D
        • Contact:
          • Gursel Yilidiz
    • Devrek
      • Zonguldak, Devrek, Turkey
        • Recruiting
        • Devrek Devlet Hastanesi
        • Contact:
          • Gursel Yilidiz, M.D
        • Sub-Investigator:
          • Gursel Yildiz, M.D
    • Ereğli
      • Zonguldak, Ereğli, Turkey
        • Recruiting
        • Ereğlı Burcu Koç Diyaliz Merkezi
        • Contact:
        • Principal Investigator:
          • Ender Hur, M.D
      • Zonguldak, Ereğli, Turkey
        • Recruiting
        • Ereğlı Can Diyaliz Merkezi
        • Principal Investigator:
          • Ender Hur, M.D
        • Contact:
      • Zonguldak, Ereğli, Turkey
        • Recruiting
        • Ereğli Devlet Hastanesi Diyaliz Merkezi
        • Principal Investigator:
          • Ender Hur, M.D
        • Contact:
          • Ender Hur
    • Çaycuma
      • Zonguldak, Çaycuma, Turkey
        • Recruiting
        • Çaycuma Can Diyaliz Merkezi
        • Contact:
        • Sub-Investigator:
          • Gursel Yilidiz, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of hypervolemia confirmed by non-invasive bioimpedance spectroscopy technique
Time Frame: within 1 year
within 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of normal blood pressure level without using anti-hypertensive medication
Time Frame: within 1 year
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
within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Investigators

  • Principal Investigator: Ender Hur, M.D, ZKU Nephrology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 5, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZKU 2011-77-21/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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