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Inferior Vena Cava Sonography in Hemodialysis Patients and Quality of Life

Primary Purpose

Hemodialysis Complication, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
sonographic measurement of inferior vena cava diameter
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult ESRD patients receiving hemodialysis at the Hadassah Medical Center

Exclusion Criteria:

  • Pregnant women; patients treated with hemodialysis less than 3 months; significant tricuspid regurgitation; severe heart failure; inadequate sonographic window for IVCD visualization

Sites / Locations

  • Hadassah - Hebrew University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IVCD arm

conventional arm

Arm Description

IVCD-assisted determination of target post-dialysis weight

conventional determination of target post-dialysis weight

Outcomes

Primary Outcome Measures

symptomatic hypotension
rate of symptomatic hypotensive episodes during hemodialysis sessions per participant per month

Secondary Outcome Measures

self-reported quality of life
self-reported quality of life using SF-36 questionnaire
intra-dialysis clinical events
rate of events: asymptomatic hypotension; gastrointestinal upset; muscle spasm; tinnitus; headache; chest pain
unplanned hemodialysis
rate of emergency hemodialysis treatments
interdialysis ambulatory blood pressure
interdialysis 24 h ambulatory blood pressure (ABPM)

Full Information

First Posted
February 20, 2017
Last Updated
April 16, 2022
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03061552
Brief Title
Inferior Vena Cava Sonography in Hemodialysis Patients and Quality of Life
Official Title
Influence of Dry Weight Adjustment by Inferior Vena Cava Sonography in Hemodialysis Patients on Quality of Life During Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Determination of dry weight in patients with end-stage renal disease treated with hemodialysis is an unmet challenge in clinical nephrology. Current methods are imprecise, and thus many patients are hype- or hypovolemic, and suffer respective consequences such as hypertension, pulmonary congestion, cardiac hypertrophy, chronic dehydration, hypotension and shock. Several techniques have been proposed to asses hydration status in dialysis patient, among them measurement of bioimpedance and biochemical markers. Sonographic measurement of the inferior vena cava diameter (IVCD) is a method under investigation for assessing hydration status. It is available, inexpensive and efficient, yet operator-dependent. In a single-center, blinded and controlled trial it has been shown to improve clinical outcomes in patients receiving hemodialysis. In this study, we aim to assess the applicability and clinical utility of this method in our dialysis units. A crossover design is intended to examine the effect of IVCD measurement on quality of life and rate of hemodynamic adversities as compared with traditional estimation of dry weight.
Detailed Description
Introduction Patients with end-stage renal disease (ESRD) cannot regulate their fluid balance, and are dependent on dialysis for fluid removal. Fluid removal is dependent upon estimation of dry weight. Dry weight is defined as the post-dialysis weight under which a patient suffers (more often than not) from symptoms of hypotension. Today, clinical estimation of dry weight is based on physical examination. This method is inaccurate, and many patients suffer from the consequences of over- or under-estimation of their dry weight. Overestimation leads to hypertension, edema and pulmonary congestion, cardiac hypertrophy and failure. Underestimation results in chronic dehydration, hypotension, dizziness, muscle spasms, gastrointestinal disturbances, tinnitus and shock. Both over- and underestimation diminish quality of life. One of the methods proposed as objective estimators of hydration status is sonographic measurement of the inferior vena cava diameter (IVCD). Cheriex et al have determined that IVCD correlates with right atrial filling, and suggested that IVCD above 11.5 mm/m2 indicates hypervolemia, and values less than 8 mm/m2 indicate hypovolemia. Chang et al reported the only randomized controlled trial to examine quality of life and clinical outcomes of hemodialysis patients in whom IVCD was measured compared to patients in whom dry weight estimation was based solely on physical examination. They found lesser clinical mishaps and improved quality of life in the intervention group, an effect which was more pronounced in patients found to be hypovolemic. As this is the only reported randomized intervention, conducted with Asian participants, we sought to conduct a similar study in an independent hemodialysis population. Objective Examination of the quality of life consequences of dry weight estimation in ESRD patients receiving dialysis with sonographic IVCD measurement. Hypothesis We assume that adjustment of dry weight in ESRD patients receiving hemodialysis using sonographic IVCD measurements will improve quality of life. Methods Study design: single-blinded cross-over clinical trial Study population: ESRD patients receiving chronic dialysis at the Hadassah Medical Center hemodialysis units. Exclusion criteria: pregnant women; patients treated with hemodialysis less than 3 months; significant tricuspid regurgitation; severe heart failure; patients with inadequate sonographic window for IVCD visualization. Quantitative outcomes: Primary - rate of symptomatic hypotensive events during hemodialysis sessions; secondary - (1) quality of life, as evaluated using Short Form (SF)-36 questionnaire; (2) intradialysis clinical events: hypotensive episodes, gastrointestinal complaints, muscle spasm, tinnitus, headache and chest pain; (3) rate of emergent (unplanned) hemodialysis treatments; (4) average 24 h ambulatory blood pressure and sleep-related dipping. Experimental methods: hemodialysis patients undergo monthly clinical evaluation by their primary nephrologist, including history, review of peri-dialysis blood pressure, physical examination and routine labs - which are basis for the monthly adjustment of target dry weight. Measurement of IVCD index will be performed twice in each participant, at the beginning of months 1 and 3, prior to the monthly visit by the primary nephrologist. Measurement will be performed as described by Cheriex et al. The primary nephrologist will be notified of the IVCD index performed at the beginning of month 3, and will be requested to adjust target post-dialysis weight accordingly. Participants will be blinded as to whether to not the primary nephrologist has been notified of the measurement. Assessment of quality of life: self report by patients using SF-36 medical outcome study short form health survey scoring system, at the end of months 2 and 4. Ambulatory blood pressure monitoring: will be performed using Oscar-2 devices (SunTech) at the ends of months 2 and 4. Sample size analysis: calculation of sample size was guided by the primary outcome. We estimated that 4 hypotensive episodes occur across 14 monthly dialysis sessions, and that an intervention can reduce the number of episodes to 2 per 14 session. With a difference of 2 episodes and standard deviation of 2 episodes, alpha level of 0.05 and 90% power, with a 2-sided paired t-test sample size is 13 paired assessments (13 patients) (WINPEPI). Assuming incomplete followup, we intend to recruit up to 20 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication, End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVCD arm
Arm Type
Experimental
Arm Description
IVCD-assisted determination of target post-dialysis weight
Arm Title
conventional arm
Arm Type
No Intervention
Arm Description
conventional determination of target post-dialysis weight
Intervention Type
Diagnostic Test
Intervention Name(s)
sonographic measurement of inferior vena cava diameter
Intervention Description
pre-dialysis measurement of inferior vena cava diameter using echocardiography
Primary Outcome Measure Information:
Title
symptomatic hypotension
Description
rate of symptomatic hypotensive episodes during hemodialysis sessions per participant per month
Time Frame
2 months
Secondary Outcome Measure Information:
Title
self-reported quality of life
Description
self-reported quality of life using SF-36 questionnaire
Time Frame
2 months
Title
intra-dialysis clinical events
Description
rate of events: asymptomatic hypotension; gastrointestinal upset; muscle spasm; tinnitus; headache; chest pain
Time Frame
2 months
Title
unplanned hemodialysis
Description
rate of emergency hemodialysis treatments
Time Frame
2 months
Title
interdialysis ambulatory blood pressure
Description
interdialysis 24 h ambulatory blood pressure (ABPM)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult ESRD patients receiving hemodialysis at the Hadassah Medical Center Exclusion Criteria: Pregnant women; patients treated with hemodialysis less than 3 months; significant tricuspid regurgitation; severe heart failure; inadequate sonographic window for IVCD visualization
Facility Information:
Facility Name
Hadassah - Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15646404
Citation
Chang ST, Chen CL, Chen CC, Hung KC. Clinical events occurrence and the changes of quality of life in chronic haemodialysis patients with dry weight determined by echocardiographic method. Int J Clin Pract. 2004 Dec;58(12):1101-7. doi: 10.1111/j.1742-1241.2004.00124.x.
Results Reference
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PubMed Identifier
2507979
Citation
Cheriex EC, Leunissen KM, Janssen JH, Mooy JM, van Hooff JP. Echography of the inferior vena cava is a simple and reliable tool for estimation of 'dry weight' in haemodialysis patients. Nephrol Dial Transplant. 1989;4(6):563-8.
Results Reference
background
PubMed Identifier
21288353
Citation
Abramson JH. WINPEPI updated: computer programs for epidemiologists, and their teaching potential. Epidemiol Perspect Innov. 2011 Feb 2;8(1):1. doi: 10.1186/1742-5573-8-1.
Results Reference
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Inferior Vena Cava Sonography in Hemodialysis Patients and Quality of Life

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