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Glucose in Dialysis Water in Non-diabetics

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ClinicalTrials.gov Identifier: NCT00439023
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : September 15, 2015
Sponsor:
Information provided by:
Regional Hospital Holstebro

Tracking Information
First Submitted Date  ICMJE February 20, 2007
First Posted Date  ICMJE February 22, 2007
Last Update Posted Date September 15, 2015
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Effect of glucose in dialysis water on blood pressure, insulin and vasoactive hormones [ Time Frame: one week ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
Effect of glucose in dialysis water on blood pressure, insulin and vasoactive hormones
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Relationship between changes in blood pressure and changes in hormones during treatment [ Time Frame: one week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
Relationship between changes in blood pressure and changes in hormones during treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose in Dialysis Water in Non-diabetics
Official Title  ICMJE Effect of Glucose in Dialysis Water on Blood Pressure and Vasoactive Hormones in Dialysis Patients
Brief Summary

The purposes are

  1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and
  2. to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other
Detailed Description Measurement of hormones and blood pressure during dialysis treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Failure, Chronic
Intervention  ICMJE Procedure: dialysis with glucose in dialysis water
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2007)
18
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age > 18 years,
  2. Both men and women,
  3. Dialysis treatment for at least three months

Exclusion Criteria:

  1. Heart failure,
  2. Chronic liver disease,
  3. Diabetes mellitus,
  4. Malignant disease,
  5. Nephrotic syndrome,
  6. Lack of compliance, 7 Unwillingness to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00439023
Other Study ID Numbers  ICMJE MED.RES.2007.01.EBP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Regional Hospital Holstebro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Erling B Pedersen, Professor Regional Hospital Holstebro
PRS Account Regional Hospital Holstebro
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP