NCT03057392

Brief Summary

Immersion to the neck before and during hemodialysis session may increase intravascular volume, potentiate the ability to ultrafiltrate excess water, with less symptoms of shock, muscle crumps etc. The aim of the present study is to compare blood volume, hemodynamic and endocrine parameters of chronic ESRD patients undergoing forth dialysis session in water immersion vs. control regular session.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 years until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

June 11, 2014

Last Update Submit

April 18, 2017

Conditions

Intradialytic HypotensionImmersion

Keywords

immersionultrafiltrationdialysis

Outcome Measures

Primary Outcomes (1)

  • symptomatic hypotension during dialysis

    a decrease of systolic BP of 22mmHG or more or decrease of diastolic BP of 10 mmHg or more accompanied with symptoms of muscle crumps, presyncope or syncope

    3 hours

Secondary Outcomes (2)

  • blood pressure changes compared to baseline

    3 hours every 15 min

  • Atrial natriuretic peptide change compared to baseline

    0, 1, 3 hours

Study Arms (2)

immersion and them sham procedure

EXPERIMENTAL

hemodialysis patients will do a 3 hours dialysis session while sitting in a bath and then have a "dry session" outside the bath

Other: immersion

sham session and then immersion

SHAM COMPARATOR

dialysis patients will have a 3 hour dialysis session (dry session) and then immersion

Other: sham session

Interventions

immersionOTHER

participants will sit in a 34-35C while receive dialysis

immersion and them sham procedure
sham sessionOTHER

dialysis while sitting in the dialysis chair

sham session and then immersion

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic hemodialysis patients

You may not qualify if:

  • anemia (HB\<10) active infectious disease cognitive impairment dialysis access installed in the leg inability to cooperate with the study procedure Clinically evident overhydrated patients(edema, pulmonary congestion, pulmonary effusion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialysis Clinic in Asaf Harofhe Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Interventions

Immersion

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

February 20, 2017

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

IL(1)