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Head Out Water Immersion for Hemodynamic Stability During Dialysis

Primary Purpose

Intradialytic Hypotension, Immersion

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
immersion
sham session
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intradialytic Hypotension focused on measuring immersion, ultrafiltration, dialysis

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic hemodialysis patients

Exclusion Criteria:

  • 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)

Sites / Locations

  • Dialysis Clinic in Asaf Harofhe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

immersion and them sham procedure

sham session and then immersion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood pressure changes compared to baseline
analysis by electronic sphygmomanometer every 15 minutes during the session
Atrial natriuretic peptide change compared to baseline
blood will be drown from arterial line at baseline, after one hour and after 3 hours before dialysis termination.

Full Information

First Posted
June 11, 2014
Last Updated
April 18, 2017
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03057392
Brief Title
Head Out Water Immersion for Hemodynamic Stability During Dialysis
Official Title
The Effect of Head Out Water Immersion During Dialysis on Clinical Parameters, Hemodynamic Parameters, and Hormonal Parameters in 10 Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
10 chronic hemodialysis patients, treated in the hemodialysis unit of Asaf-Harofeh Medical Center will be enrolled in the study. Hemoglobin and albumin will be detected at baseline, and a recent (less than one year) echo will be used for the detection of ejection fraction. The study will be a cross over study. Each set of studies will consist of two dialysis sessions, an immersion session, and a dry, non-immersion session. The study sessions will be short, 3 hours sessions with 250-350 ml/min blood flow (depends on the patients access) dialysate flow was 500 ml/min and dialysate sodium was 137meq/l. The temperature of the dialysate will be adjusted to 37°C and its composition as follows: Na+ = 137 mEq/L, K+ = 2.0 mEq/L, Ca2+ = 3.0 mEq/L, Mg2+ = 1.0 mEq/L, HCO3-= 30 mEq/L, glucose =100 mg/dL, CH3COO-= 8 mEq/L. The sodium concentration will be constant during treatment. Ultrafiltration will be determined as the mean of UF during the ten previous sessions±10% according to the patients weight on admission. The immersed and dry session will be done in the midweek sessions, in random order, at least one week apart from each other. Head-Out Water Immersion A bath will be used for immersion. The bath will be filled with purified water before each of the session, and will be heated to 34-35°C. Patients will enter the bath and sat upright for few minutes and then connected to dialysis. The water will circulate through a thermostats and heating device in order to maintain a constant temperature. Patients with arterio-venous fistula or graft in their arm will be immersed in water up to their axilla, with their arm lining on a floating pad. For patients with perm-cath immersion will only be done up to 5 cm below the catheter insertion. Study procedure Subjects will enter the bath and sit for few minutes, after which blood samples will be drown for baseline measurement. During the session blood pressure and heart rate will be measured every 15 minutes by conventional sphygmomanometry. and blood volume will be estimated by using blood volume monitor (Crit-Line). Blood samples will be drown at baseline and after one hour, and before caseation of the session for plasma renin activity, aldosterone, atrial natriuretic peptide. Baseline and end of session urea will also measured for URR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension, Immersion
Keywords
immersion, ultrafiltration, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immersion and them sham procedure
Arm Type
Experimental
Arm Description
hemodialysis patients will do a 3 hours dialysis session while sitting in a bath and then have a "dry session" outside the bath
Arm Title
sham session and then immersion
Arm Type
Sham Comparator
Arm Description
dialysis patients will have a 3 hour dialysis session (dry session) and then immersion
Intervention Type
Other
Intervention Name(s)
immersion
Intervention Description
participants will sit in a 34-35C while receive dialysis
Intervention Type
Other
Intervention Name(s)
sham session
Intervention Description
dialysis while sitting in the dialysis chair
Primary Outcome Measure Information:
Title
symptomatic hypotension during dialysis
Description
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
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
blood pressure changes compared to baseline
Description
analysis by electronic sphygmomanometer every 15 minutes during the session
Time Frame
3 hours every 15 min
Title
Atrial natriuretic peptide change compared to baseline
Description
blood will be drown from arterial line at baseline, after one hour and after 3 hours before dialysis termination.
Time Frame
0, 1, 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic hemodialysis patients Exclusion Criteria: 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)
Facility Information:
Facility Name
Dialysis Clinic in Asaf Harofhe Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel

12. IPD Sharing Statement

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Head Out Water Immersion for Hemodynamic Stability During Dialysis

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