End Stage Kidney DiseaseNCT02792530
Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain
A study testing Dietary consultation in people with End Stage Kidney Disease, run by Rabin Medical Center.
Trial summary
This study will evaluate the efficiency of dietary intervention on intradialytic weight gain. Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Dietary consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years providing signed informed consent.
- Any patient more than 3 months in hemodialysis who reach his assigned dry weight.
- Intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions.
- residual renal function of less than 200 ml per 24 hr.
- expected to stay on hemodialysis for at least 6 month.
Who cannot join
- Malnutrition as assessed by SGA: score C.
- Dementia
- Active malignancy
- Active infection
Trial locations and contacts
No sites are listed yet.
About this study
This study will evaluate the efficiency of dietary intervention on intradialytic weight gain. Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. One month after the intervention, their intradialytic weight accumulation will be measured.
Read the detailed description
Inter Dialytic Weight Gain (IDWG) ascribed to fluid retention is one of the major clinical problem that patients in hemodialysis need to cope with between 2 subsequent hemodialysis especially in patients with no residual renal function. Fluid retention is associated with morbid conditions such as lower-extremity edema, ascites, pulmonary vascular congestion or edema, hypertension, and worsening heart failure. Gain weight above 2 kg between 2 subsequent hemodialysis found to be in higher risk of all-cause mortality and cardiovascular death .Lowering daily sodium intake found to mitigate fluid retention ,however there are only a few researches that check it. 2IDWG also associated with poorer quality of life. Dietary sodium restriction recommendation since the beginning of hemodialysis are based on association of this restriction with balance of hypertension and fluid retention. Sodium intake recommended for patients in hemodialysis is limited to 2 grams a day. Nevertheless, there are only a few studies that examine the efficiency of this restriction because of the complexity of measurement of sodium intake. One recently published study which used a 24-h recall to measure sodium intake, found a direct correlation between IDGW and mortality form any reason. In spite of this complexity, IDWG has been found to be in a direct relation with patients' nutrition status.
One of sodium-related issues is malnutrition. Malnutrition in dialysis is a risk factor for patients' morbidity and mortality. Higher sodium intake is associated with higher calorie and protein intake, while adherence to restriction of sodium intake is poor in hemodialysis. This is a reason for high importance to study effects of sodium restriction in people with more than 2.5 kg (or 4% of dry body weight) IDWG while following up their nutritional status
- Conditions
- End Stage Kidney Disease
- Being tested
- Dietary consultation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary consultationOther
Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Other | Unuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention. Receives: Other: Dietary consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in intradialytic weight gain (IDWG)
Reduction in the weight gain at 2 subsequent hemodialysis in KG/
Measured: between baseline and 6 weeks
Secondary outcomes (6)
dietary sodium intake.
as measured by food recall assesment
Measured: at baseline and 6 weeks
Change in CRP values
Measured: between baseline and 6 weeks
Changes in subjective global assesment (SGA)
SGA is a nutritional assesment measure
Measured: between baseline and 6 weeks
change in predialysis blood pressure
Measured: between baseline and 6 weeks
Changes in quality of life
assessed by SF 36
Measured: between baseline and 6 weeks
number of hypotensive episode during dialysis
define as drop of more than 20 mm hg systolic blood pressure from baseline
Measured: at baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792530
- Sponsor's protocol ID
- 0654-15-RMC
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Sodium Intake in Anuric Hemodialysis Patients and Interdialytic Weight Gain
- ClinicalTrials.gov ID
- NCT02792530
- Acronym / sponsor ID
- 0654-15-RMC
- Conditions
- End Stage Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- 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.
This study will evaluate the efficiency of dietary intervention on intradialytic weight gain. Uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. One month after the intervention, their intradialytic weight accumulation will be measured.
Detailed description
Inter Dialytic Weight Gain (IDWG) ascribed to fluid retention is one of the major clinical problem that patients in hemodialysis need to cope with between 2 subsequent hemodialysis especially in patients with no residual renal function. Fluid retention is associated with morbid conditions such as lower-extremity edema, ascites, pulmonary vascular congestion or edema, hypertension, and worsening heart failure. Gain weight above 2 kg between 2 subsequent hemodialysis found to be in higher risk of all-cause mortality and cardiovascular death .Lowering daily sodium intake found to mitigate fluid retention ,however there are only a few researches that check it. 2IDWG also associated with poorer quality of life. Dietary sodium restriction recommendation since the beginning of hemodialysis are based on association of this restriction with balance of hypertension and fluid retention. Sodium intake recommended for patients in hemodialysis is limited to 2 grams a day. Nevertheless, there are only a few studies that examine the efficiency of this restriction because of the complexity of measurement of sodium intake. One recently published study which used a 24-h recall to measure sodium intake, found a direct correlation between IDGW and mortality form any reason. In spite of this complexity, IDWG has been found to be in a direct relation with patients' nutrition status.
One of sodium-related issues is malnutrition. Malnutrition in dialysis is a risk factor for patients' morbidity and mortality. Higher sodium intake is associated with higher calorie and protein intake, while adherence to restriction of sodium intake is poor in hemodialysis. This is a reason for high importance to study effects of sodium restriction in people with more than 2.5 kg (or 4% of dry body weight) IDWG while following up their nutritional status
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Other | Other: Dietary consultationUnuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults >18 years providing signed informed consent.
- Any patient more than 3 months in hemodialysis who reach his assigned dry weight.
- Intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions.
- residual renal function of less than 200 ml per 24 hr.
- expected to stay on hemodialysis for at least 6 month.
Key exclusion criteria (4 listed)
- Malnutrition as assessed by SGA: score C.
- Dementia
- Active malignancy
- Active infection
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 |
|---|---|---|
| Dietary consultationDietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently | Other | arm 1 |
Primary outcome
Reduction in intradialytic weight gain (IDWG)
Time frame: between baseline and 6 weeks
Reduction in the weight gain at 2 subsequent hemodialysis in KG/
6 secondary outcomes
dietary sodium intake.
Time frame: at baseline and 6 weeks
Change in CRP values
Time frame: between baseline and 6 weeks
Changes in subjective global assesment (SGA)
Time frame: between baseline and 6 weeks
change in predialysis blood pressure
Time frame: between baseline and 6 weeks
Changes in quality of life
Time frame: between baseline and 6 weeks
number of hypotensive episode during dialysis
Time frame: at baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary consultation in people with End Stage Kidney Disease, run by Rabin Medical Center.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benaya Rozen Zvi,., Ph.D (972-50-8773766, bnaiar@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in intradialytic weight gain (IDWG) (time frame: between baseline and 6 weeks). 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 10 Jun 2016.