Inferior Vena Cava Sonography in Hemodialysis Patients and Quality of Life

NCT03061552 | Completed

• 1 other identifier: 032416-HMO-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• symptomatic hypotension

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

  2 months

Secondary Outcomes (4)

• self-reported quality of life

  2 months

• intra-dialysis clinical events

  2 months

• unplanned hemodialysis

  2 months

• interdialysis ambulatory blood pressure

  2 months

Study Arms (2)

IVCD arm

EXPERIMENTAL

IVCD-assisted determination of target post-dialysis weight

Diagnostic Test: sonographic measurement of inferior vena cava diameter

conventional arm

NO INTERVENTION

conventional determination of target post-dialysis weight

Interventions

sonographic measurement of inferior vena cava diameter DIAGNOSTIC_TEST

pre-dialysis measurement of inferior vena cava diameter using echocardiography

IVCD arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ESRD patients receiving hemodialysis at the Hadassah Medical Center

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah - Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (3)

• 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.

  PMID: 15646404 BACKGROUND

• 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.

  PMID: 2507979 BACKGROUND

• 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.

  PMID: 21288353 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: March 31, 2022
• Last Updated: April 20, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)