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Head Out Water Immersion for Hemodynamic Stability During Dialysis

The Effect of Head Out Water Immersion During Dialysis on Clinical Parameters, Hemodynamic Parameters, and Hormonal Parameters in 10 Hemodialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03057392
Enrollment
10
Registered
2017-02-20
Start date
2013-05-31
Completion date
2015-03-31
Last updated
2017-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intradialytic Hypotension, Immersion

Keywords

immersion, ultrafiltration, dialysis

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.

Interventions

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

OTHERsham session

dialysis while sitting in the dialysis chair

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
symptomatic hypotension during dialysis3 hoursa 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

MeasureTime frameDescription
blood pressure changes compared to baseline3 hours every 15 minanalysis by electronic sphygmomanometer every 15 minutes during the session
Atrial natriuretic peptide change compared to baseline0, 1, 3 hoursblood will be drown from arterial line at baseline, after one hour and after 3 hours before dialysis termination.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026