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Body Fluid Dynamics in Hemodialysis Patients, an Estimation of Dry Weight

22 februari 2016 uppdaterad av: Renal Research Institute

Evaluation of Body Hydration Status in Hemodialysis Patients Using Segmental Bioimpedance Analysis

The purpose of this study is to learn how the amount of fluid in the body of a hemodialysis patient affects him or her. Body hydration is the amount of fluid in the human body and known to be related to blood pressure. Too much fluid can lead to high blood pressure which can cause heart problems and eventually lead to death. Bioimpedance Spectroscopy (BIS) is a method that may be used to measure body hydration. This can be applied in the whole body, arm, trunk, calf, and leg. It is a non-invasive and inexpensive method and no known risk. BIS measurements can be used to assess optimal hydration status which is defined as a patient's ideal weight after completing a dialysis treatment. The investigators hypothesize that your target weight may be better estimated by the BIS. The results of this study, in particular the continuous measurement of calf hydration which is associated with the hydration of the whole body, may provide useful information about physiologic ("healthy") body hydration. It may possibly help to improve treatment procedures for patients in the future. The Renal Research Institute plans to enroll 100 chronic hemodialysis patients and 200 healthy controls in this study.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Estimation of the hydration state of chronic kidney disease (CKD) patients is an important aspect of clinical practice. Deterioration in renal function often leads to volume overload with resulting hypertension and there is no simple and accurate technique available to measure body hydration at the moment.

In hemodialysis (HD) patients, one limitation to adequate ultrafiltration necessary to achieve optimal hydration status (dry weight) is inadequate vascular refilling from the interstitial space. Blood pressure may decrease due to limitation of vascular refilling even when dry weight is far from being achieved. Therefore, an objective and accurate method to provide hydration state would be very useful for clinical practice. Whole body bioimpedance techniques have been used to measure body fluid volume for many years. However, it is difficult to accurately indicate the hydration state by body fluid volume of normal variations, and the accuracy of measurement is influenced by various body compositions. Recently, the investigators have proposed that hydration can be approached using a calf bioimpedance technique by monitoring change in resistance during HD. Since the lower limbs tend to contain more fluid than other body segments in ambulatory people due to the effect of gravity, measurement of the calf provides more accurate information about body hydration in the HD patient.

In this study, the investigators hypothesize that:

  1. Since the degree of hydration is greater in the leg than in the arm and the trunk due to the effect of gravity, monitoring change in resistance in the whole or part of the leg will provide information as to whether optimal hydration status (a state in which excess extracellular fluid is absent) has been attained. The investigators postulate that a change in the slope of resistance curve (CSR) in the calf approaches zero as optimal hydration status is achieved.
  2. Optimal hydration status can be approximated by comparison of two values: (1) measurement of local electrical resistivity in the interstitial compartment and (2) known range of resistivity in healthy subjects (HS). Combination of the normalized resistivity (μ) and CSR are considered as indicators of physiological optimal hydration status. Physiological optimal hydration status, as an objective index, is a major goal of hemodialysis so that the excess body water can be maximally removed according to this value. In practice this can be approached but should never be exceeded.

Because flattening of the curve should be verified by the near normal resistivity, a group of healthy subjects would have to be added to provide a normal range of resistivity at all ages and both sexes.

Studietyp

Observationell

Inskrivning (Faktisk)

89

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Stable hemodialysis patients believed to be at all levels of hydration by their treating physician will be chosen. 100 subjects will be chosen to include approximately 50% women in the hemodialysis program. Subjects will be selected from a wide range of ages and body mass indexes

Beskrivning

Inclusion Criteria:

  • Stable hemodialysis patients believed to be at all levels of hydration by their treating physician should be chosen.

Exclusion Criteria:

  • Myocardial infarction or stroke in the preceding 6 months
  • Two episodes of hypotension (systolic BP < 90 mmHg) during the 3 dialysis procedures preceding entering the treatment phase
  • Grade IV CHF by NY classification
  • Simultaneous participation in another clinical study except observational trials.
  • Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
  • Pregnancy.
  • Amputation of a limb.
  • Pace maker, implantable pump, artificial joint.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Hemodialysis patients
Dialysis patients will have their estimated dry weight measured with calf segmental bioimpedance. Based on these measurements, their dry weight will be adjusted and the amount of fluid removed during subsequent dialysis treatments will be increased by 200-300mL. The additional fluid removal will occur during 3 consecutive hemodialysis sessions. In addition, these subjects will also use VStim during these treatments. to prevent common intradialytic symptoms by promoting vascular refilling.
Healthy Controls
No Intervention was administered. Both groups had their hydration status measured with segmental bioimpedance The group of healthy subjects was studied in order to obtain a range of values for normal hydration status.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Dry weight as determined by segmental bioimpedance in comparison to baseline
Tidsram: 1 month
1 month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean pre dialysis and post dialysis blood pressure in comparison to baseline
Tidsram: 1 month
1 month
Numbers and doses of blood pressure medications prescribed
Tidsram: 1 month
If the blood pressure is improved based on better assessment of dry weight, the need for multiple blood pressure meds and dosing will be reduced.
1 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Fansan Zhu, MD, Renal Research Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2008

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 februari 2015

Studieregistreringsdatum

Först inskickad

16 december 2014

Först inskickad som uppfyllde QC-kriterierna

19 december 2014

Första postat (Uppskatta)

25 december 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 februari 2016

Senast verifierad

1 februari 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • RRI091-97

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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