NCT02792530

Brief 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. One month after the intervention, their intradialytic weight accumulation will be measured.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

June 10, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

April 12, 2016

Last Update Submit

June 9, 2016

Conditions

End Stage Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Reduction in intradialytic weight gain (IDWG)

    Reduction in the weight gain at 2 subsequent hemodialysis in KG/

    between baseline and 6 weeks

Secondary Outcomes (6)

  • dietary sodium intake.

    at baseline and 6 weeks

  • Change in CRP values

    between baseline and 6 weeks

  • Changes in subjective global assesment (SGA)

    between baseline and 6 weeks

  • change in predialysis blood pressure

    between baseline and 6 weeks

  • Changes in quality of life

    between baseline and 6 weeks

  • +1 more secondary outcomes

Study Arms (1)

arm 1

OTHER

Unuric hemodialytic patients who accumulate above 2.5 (4%) in intradialytic intervals before the nutritional intervention.

Other: Dietary consultation

Interventions

Dietary consultationOTHER

Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently

arm 1

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Malnutrition as assessed by SGA: score C.
  • Dementia
  • Active malignancy
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Benaya Rozen Zvi,., Ph.D

CONTACT

972-50-8773766bnaiar@clalit.org.il

Merav Jacobson Naftali

CONTACT

972-50-7778369merav.j.n@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

June 7, 2016

Study Start

August 1, 2016

Primary Completion

May 1, 2017

Last Updated

June 10, 2016

Record last verified: 2016-04