NCT00313430

Brief Summary

The investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. They presume that these abilities become poorer when renal insufficiency progresses. The investigators further hypothesize that patients with hypertension also have a decreased ability to concentrate and dilute urine.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

April 11, 2006

Last Update Submit

August 19, 2015

Conditions

Keywords

Urine concentration abilitychronic renal insufficiencyhypertensionaquaporin2Patients with chronic renal insufficiencyPatients with hypertensionHealthy volunteers

Study Arms (2)

Dialysis patients

with or wthout glucose added to dialysis fluid

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants were recruited by advertisements in public and private institutions Patients with primary hypertension or chronic renal failure were recruited from the Out-patients' Clinic, Department of Medicine, Section of Nephrology, Holstebro Hospital

You may qualify if:

  • Patients with chronic renal insufficiency, aged between 18 and 65, both men and women
  • Creatinine clearance between 30-59 ml/min
  • Patients with hypertension, aged between 18 and 65, both men and women; hypertension is defined as a mean arterial blood pressure in the daytime that is more than 140/90 mm Hg.
  • Healthy volunteers, aged between 18 and 65, both men and women

You may not qualify if:

  • Clinical signs or history of disease in the heart, lungs, liver, brain, and endocrine organs
  • Cancer
  • Alcohol abuse
  • Medicine abuse
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Holstebro Hospital

Holstebro, Ringkjoebing, 7500, Denmark

Location

Related Publications (1)

  • Pedersen EB, Thomsen IM, Lauridsen TG. Abnormal function of the vasopressin-cyclic-AMP-aquaporin2 axis during urine concentrating and diluting in patients with reduced renal function. A case control study. BMC Nephrol. 2010 Oct 5;11:26. doi: 10.1186/1471-2369-11-26.

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Erling B Pedersen, Professor

    Holstebro, Holstebro, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor, chief physician

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

May 1, 2004

Primary Completion

March 1, 2008

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations