Intradialytic HypotensionNCT03057392
Head Out Water Immersion for Hemodynamic Stability During Dialysis
A study testing immersion in people with Intradialytic Hypotension and Immersion, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Intradialytic Hypotension, Immersion
- What is being tested?
- immersion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic hemodialysis patients
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Head Out Water Immersion During Dialysis on Clinical Parameters, Hemodynamic Parameters, and Hormonal Parameters in 10 Hemodialysis Patients
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.
Read the 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.
- Conditions
- Intradialytic Hypotension, Immersion
- Being tested
- immersion, sham session
- Keywords
- immersion, ultrafiltration, dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersionOther
participants will sit in a 34-35C while receive dialysis
sham sessionOther
dialysis while sitting in the dialysis chair
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: immersion |
| sham session and then immersion | Sham comparator | dialysis patients will have a 3 hour dialysis session (dry session) and then immersion Receives: Other: sham session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (2)
blood pressure changes compared to baseline
analysis by electronic sphygmomanometer every 15 minutes during the session
Measured: 3 hours every 15 min
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.
Measured: 0, 1, 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startMay 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057392
- Sponsor's protocol ID
- 73/12
- Status last verified
- Apr 2017
- First submitted
- 11 Jun 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head Out Water Immersion During Dialysis on Clinical Parameters, Hemodynamic Parameters, and Hormonal Parameters in 10 Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03057392
- Acronym / sponsor ID
- 73/12
- Conditions
- Intradialytic Hypotension, Immersion
- Keywords
- immersion, ultrafiltration, dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immersion and them sham procedure | Experimental | Other: immersionhemodialysis patients will do a 3 hours dialysis session while sitting in a bath and then have a "dry session" outside the bath |
| sham session and then immersion | Sham comparator | Other: sham sessiondialysis patients will have a 3 hour dialysis session (dry session) and then immersion |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic hemodialysis patients
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immersionparticipants will sit in a 34-35C while receive dialysis | Other | immersion and them sham procedure |
| sham sessiondialysis while sitting in the dialysis chair | Other | sham session and then immersion |
Primary outcome
symptomatic hypotension during dialysis
Time frame: 3 hours
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
2 secondary outcomes
blood pressure changes compared to baseline
Time frame: 3 hours every 15 min
Atrial natriuretic peptide change compared to baseline
Time frame: 0, 1, 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immersion in people with Intradialytic Hypotension and Immersion, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptomatic hypotension during dialysis (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.