Change in Single Session Dialysis Adequacy [ Time Frame: After hemodialysis up to the 22 week study period ] Patients that experience symptomatic IDH may require a reduction in the duration of HD treatments with a resultant reduction in dialysis adequacy. Electrical Bio-impedance for the determination of change in hydration and fluid status [ Time Frame: At the end of the mid-week HD session at week 1, 4, 8, 12, 14, 18, and Up to week 22 study period. Improvement of dry weight has been linked with reduced mortality.
Change in Serum high sensitivity cardiac troponin hs-Troponin [ Time Frame: At the beginning of the mid-week HD session at week 1, 4, 12, 14, and Improved and more frequent dialysis has been associated with a decrease in myocardial stunning, and a trend towards decreasing hs-troponin. Serum hs-Troponin will be performed at the beginning of the mid-week HD session at week 1, 4, 12, 14, and Change in antihypertensive medication use [ Time Frame: At enrollment and the mid-week HD session at week 4, 8, 12, 14, 18, and The class and number of anti-hypertensive medications will be obtained from the electronic clinical database and subsequently confirmed with a patient interview at enrollment and the mid-week HD session at week 4, 8, 12, 14, 18, and The study investigator will perform medication reconciliation Relative blood volume Curve [ Time Frame: After every hemodialysis session, up to the 22 week study period.
The relative blood volume curve will be downloaded from the Fresenius dialysis machine to a study computer on a regular basis for all patients in the run-in phase and those in the intervention arm following randomization.
The subjective pattern of BVM curve flat, linear, concave upward, concave downward, regular and irregular line will be determined by the study investigator. Improvement in Intra-dialytic symptom survey [ Time Frame: At the end of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and Up to the 22 week study period.
The survey will inquire about the intra-dialytic symptoms of IDH, specifically nausea, vomiting, chest pain, shortness of breath, headache, muscle cramps, dizziness, fainting, fatigue, and anxiety. The survey will be provided by the dialysis nurse, and to be completed by the patient or in conjunction with the dialysis nurse at the end of the dialysis session during weeks 1, 4, 8, 12, 14, 18, and The survey is expected to take less than 1 minute to complete.
Improvement in Inter-dialytic symptom survey [ Time Frame: At the beginning of each dialysis session, during weeks 1, 4, 8, 12, 14, 18, and The survey will inquire the time it took the patient to recovery from the last dialysis session, is validated in HD patients as a robust assessment quality of life.
The survey will take less than 30 seconds to complete. The survey is developed for the purpose of this study. 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.
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Search for terms. Save this study. Warning You have reached the maximum number of saved studies Adjusting Fluid Removal Based on Blood Volume in Hemodialysis: A Randomized Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : July 27, Study Description. Detailed Description:. This is a 22 week parallel group, randomized crossover trial to determine the effect of blood volume monitoring, BVM, guided ultrafiltration UF biofeedback on symptomatic intradialytic hypotension IDH episodes amongst IDH prone patients.
During this period all patients will undergo a comprehensive clinical assessment including, clinical weight assessment, anti-hypertensive medication review, and dialysis prescription standardization.
At the end of the run-in phase, patients that still meet eligibility criteria will enter the randomized cross-over phase. This will be followed by a two-week washout phase and then patients will be crossed over for a second 8-week phase.
FDA Resources. Arms and Interventions. Patients in the BVM-guided UF biofeedback intervention phase will have the same prescription as the control group but will also have the ultrafiltration rate automatically adjusted by the Fresenius HD machine based on the changes in the relative blood volume. The Fresenius uses an ultrasound and temperature monitor incorporated into the machine to detect ultrasonic velocity and temperature changes to derive the total protein concentration, which is a sum of total plasma proteins and hemoglobin.
Outcome Measures. The number of symptomatic IDH episodes of each dialysis treatment will be captured. Patients that experience symptomatic IDH may require a reduction in the duration of HD treatments with a resultant reduction in dialysis adequacy. Whole body and segmental bio-impedance analysis for the determination of fluid composition has been validated in HD patients.
Chronic hypervolemia in HD is associated with increase in left atrial volume and BNP, which has been shown to predict mortality. Biomarkers of cardiac damage such as hs-Troponin are more elevated in HD patients with myocardial stunning and is associated with an increased all-cause mortality.
Improvements in a patient's volume status and blood pressure allows for a decrease number or dose of anti-hypertensive medications. The study investigator will perform medication reconciliation. The shape and slope of the RBV curve has been associated with symptomatic hypotensive episodes in HD.
Currently no validated intra-dialytic symptom survey exists to provide an objective measure of intra-dialytic symptom burden. A survey inquiring about inter-dialytic recovery time to baseline will be provided by the dialysis nurse, and to be completed by the patient or in conjunction with the dialysis nurse at the beginning of dialysis during weeks 1, 4, 8, 12, 14, 18, and A survey inquiring about nursing perception and attitudes of the BVM guided UF biofeedback will be provided to the nurses at the end of the control and intervention phase.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Able to provide written informed consent. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. The mortality risk of overhydration in haemodialysis patients. Subjects are given time to read and understand the statements before signing consent and dating the document. Subjects receive a copy of the signed written statement and the original copy of the informed consent is stored in the investigator study files. No subject is entered into the study until informed consent has been obtained.
Safety assessments include the monitoring and recording of all adverse events AE , including serious adverse events SAE. An AE is any undesirable experience associated with the use of a medical product or procedure in a patient. The most probable AEs caused by dry weight reduction are cramps and hypotension. The expected intra- and post-dialytic symptoms are provided in Table 1. The most probable serious adverse events caused by dry weight reduction are vascular-access-related hospitalizations, and aggravated consequences of postdialysis hypotension, such as fractures due to falling.
Execution of the three techniques under investigation is crucial. Evaluation of the success of UCR and UTR will be evaluated at the end of the first study phase for all available treatments and will include at least the following parameters:.
Specifically, the number of treatments during the run-in phase with an available reference line will be reported per patient, and per all of the treatments during the run-in phase. Delayed input of the ultrafiltration goal during the study phase. Incorrect input of the ultrafiltration goal during the study phase. Specifically, the number of treatments during the study phase with an incorrect input of the ultrafiltration goal will be reported per patient, and per all of the treatments during the study phase.
Inadequate display of the ultrafiltration rate and conductivity during the study phase. Specifically, the number of treatments during the study phase with an inadequate display of the ultrafiltration rate and conductivity during the study phase will be reported per patient, and per all of the treatments during the study phase.
The statistical analysis plan SAP provides full details regarding the analyses, the data display, and the algorithms to be used for data derivations. The SAP includes the definition of major and minor protocol deviations, which will be identified by medically trained staff before the study closure.
Safety and tolerability are analyzed descriptively. Safety analysis is performed on the intention-to-treat ITT population. All secondary endpoint analyses are exploratory in nature. Sample size calculation: for the primary endpoint analysis, we will assess the differences in intradialytic complications between the three study groups, only during the first study phase. Based on a typical occurrence of 0. The UCR and UTR groups will be tested against the conventional hemodialysis control group, and afterward against one another.
If patients are lost to follow-up, they will be excluded from the analysis. Two different analysis sets are defined for safety and efficacy, respectively. The efficacy of UCR and UTR will be assessed in all subjects who received the study method at least once and did not violate the protocol in a way that might affect the evaluation of the effect of the study method on the primary objective, that is, without major protocol violations.
The per-protocol set is employed in the analysis of efficacy variables. The safety analysis set includes subjects who were randomized and received at least one study method modified intention-to-treat. The safety set is employed in the analysis of tolerability and safety variables. Statistical analysis is performed with SAS.
The trial is performed in accordance with the Declaration of Helsinki. It subscribes to the principles outlined in the most recent version of the International Conference on Harmonization on Good Clinical Practice.
Recent data show prospectively that fluid control based on BCM measurements and proper adjustment of dry weight is feasible [ 53 ]. Last, the first prospective experiences with the intervention of BCM-based correction of volume status for example, lower dry weight prescription support the mortality benefit of normohydration, shown in the previous association study, where fluid status was assessed once, using BCM, and patients were thereafter followed over three and a half years [ 8 ] As a consequence, we expect a direct benefit for all patients participating in this study, because lower dry weight will be prescribed in all three study groups.
The results of the CLIMB study [ 20 ], as well as experiences from previous clinical trials, have indicated that BVM is complicated, and have made its use controversial. For example, Andrulli et al. On the contrary, Barth et al. The results of Tonelli et al. And finally, Mitra et al. The present study, however, by using prespecified response options to BVM is intended to overcome these previous controversies.
Withdrawal of antihypertensives, in order to reach lower dry weight, may, to some dialysis care takers, seem unethical. However, blood pressure treatment in hemodialysis patients is highly controversial. Although blood pressure control may be the most extensively studied area in dialysis research, widely accepted propositions for the treatment of hypertension are still missing [ 55 , 56 ], mainly because epidemiologic studies have failed to incriminate hypertension as a cardiovascular risk factor [ 57 ].
Oral pharmacotherapy has recently been shown to yield some mortality benefit [ 58 , 59 ], but data from single centers in Uruguay [ 60 ], United Kingdom [ 61 ], Turkey [ 62 ] and Tassin, France [ 63 ] have consistently demonstrated that strict volume control with relatively low postdialysis dry weight targets can fully normalize the blood pressure in a great majority of hemodialysis patients.
In fact, hypertension control without antihypertensive medication is actually the strongest predictor of survival in hemodialysis patients [ 64 ]. Therefore, it is ethical to withdraw antihypertensives in order to reach the adequate dry weight target, and this approach has been used before, in the DRIP trial, which did not include patients based on bioimpedance-based detection of fluid overload, but based on hypertension [ 11 ]. We have recently shown that higher DNa prescriptions are associated with IDWG, but not with worse outcomes, and that predialysis serum sodium concentrations correlate inversely with mortality risk [ 49 , 67 ].
Among secondary outcome parameters, principal emphasis will be placed on a measurement of intradialytic sodium balance listed as secondary objective c. This analysis is necessary, as there is only one previous publication, which estimated, but did not measure sodium transfer through positive dialysate-to-serum sodium gradients [ 68 ]. The results of our investigation may help dialysis physicians in their decision concerning the dialysate sodium prescription, because they will be able to anticipate which amount of sodium is transferred during hemodialysis.
As it has been shown that increased cardiovascular biomarkers such as N-terminal pro-B-type natriuretic peptide, D-dimer and troponin T are strongly correlated with inflammation as well as higher cardiovascular mortality in hemodialysis patients [ 69 — 71 ], it will be impor-tant to assess whether systematic dry weight reduction improves the chronic inflammatory state associated with hemodialysis.
These categories shall ensure that enrolled patients are maximally protected from discomfort, since they can report necessary occurrences, even postdialysis. In consequence, fluid withdrawal rates are reduced at the subsequent hemodialysis sessions. Based on our working experience, the great majority of dialysis nurses are aware of the importance of symptom-free hemodialysis sessions, since discomfort is almost always reported to the nurses first.
However, how can it be ensured that patients are monitored in the same way? In addition, it would have been very unrealistic to successfully blind the treatment UCR, UTR, conventional hemodialysis.
The lack of blinding, in combination with the above-mentioned subjectivity of patients and nurses, can introduce bias into the study. By instructing dialysis caretakers to remain as objective as possible toward the treatments under investigation, we anticipate that our study will still yield informative results.
To the best of our knowledge, this is the first study that combines bioimpedance measurements for assessment of volume status and BVM response options. As a consequence, patients may benefit from two entirely unrelated concepts in modern fluid management, with potential impact not only on intradialytic stability, but also dialysis-associated factors such as residual renal function, inflammation, and quality of life.
Ultimately, applying the dialysis treatment that proves superior in the present study may translate into improved dialysis outcomes. At the time of manuscript submission, the present study - overall - is still recruiting participants ClinicalTrials. Kidney Int Suppl. Blood Purif. Physiol Meas. Article PubMed Google Scholar. J Am Soc Nephrol.
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Contrib Nephrol. A short-term clinical study. Polaschegg HD: Device for treating blood in an extracorporeal system. European Patent EP, priority Levin NW, Kotanko P: Is cool dialysis an effective and well-tolerated means of reducing the frequency of intradialytic hypotension?.
Nat Clin Pract Nephrol. Donnan F: The theory of membrane equilibria. Chem Rev. Life Support Syst. In J Am Soc Nephrol. J Ren Nutr. Clin J Am Soc Nephrol. Am J Nephrol. She R: Research Randomizer Version 3. Epub Jan. Agarwal R, Weir MR: Dry-weight: a concept revisited in an effort to avoid medication-directed approaches for blood pressure control in hemodialysis patients. Agarwal R, Sinha AD: Cardiovascular protection with antihypertensive drugs in dialysis patients: systematic review and meta-analysis.
Charra B: Control of blood pressure in long slow hemodialysis. Lindley EJ: Reducing sodium intake in hemodialysis patients. Semin Dial. Med Sci Monit. Download references. We thank Peter Wabel and Friedrich K. Port for revising the present manuscript and advising us on several aspects of the study protocol, in particular BCM-measurements Peter Wabel and aspects related to dialysis outcomes, sodium and hypertension Friedrich K.
We also thank nurses Peter Klotz, Werner Mayer and Josef Schwarzmann, for excellent advice concerning the technical feasibility of this study. You can also search for this author in PubMed Google Scholar. This academic study is sponsored by the Medical University of Vienna, Austria. The authors received an unrestricted research grant from Nikkiso Ltd.
MH, MA and MS are responsible for all aspects of this trial; in particular, they designed the study, wrote and revised the manuscript, are registering study patients and are surveying the study at the Chronic Hemodialysis Facility 1 of the Medical University of Vienna. JW, MH and TW designed the secondary endpoint analyses listed under f , and revised the present manuscript. H-DP contributed intellectually to all technical aspects of this study, designed the secondary endpoint analysis listed under d , and revised the present manuscript.
PJ advised us on, and planned the technical aspects of UCR, and also wrote the part on quality control. All authors read and approved the final manuscript. Reprints and Permissions. Hecking, M. Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial.
Trials 13, 79 Download citation. Received : 21 January Accepted : 08 June Published : 08 June Anyone you share the following link with will be able to read this content:.
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