Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Renal Blood Flow During Human Endotoxemia
This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, December 2006
Sponsored by: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00413465
  Purpose

The purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.


Condition Intervention
Healthy
Type 2 Diabetes
Endotoxemia
Drug: Escherichia Coli Endotoxin

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Renal Plasma Flow During Experimental Human Endotoxemia

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Renal plasma flow, Glomerular filtration rate, Plasma cytokine content, Endotoxemia score, Plasma angiotensin II and renin content, Plasma thromboxane B2 content, Plasma PAI-1 content

Secondary Outcome Measures:
  • Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,

Estimated Enrollment: 32
Study Start Date: November 2006
Estimated Study Completion Date: December 2007
Detailed Description:

Many septic patients develop acute renal failure and the risk is higher in patients with diabetes. The pathogenetic mechanisms behind the development of acute renal failure in connection with sepsis is not completely understood. One among many possible explanations is a change in renal hemodynamics. However, it is still largely unknown what happens to the renal plasma flow during human sepsis. In this study we give endotoxin injection (0,3 ng/kg) to type 2 diabetics and healthy controls as an experimental model of sepsis. Renal plasma flow and glomerular filtration rate are measured by DTPA-renography 1 day before before and 1,25 and 6,5 hours after injection of endotoxin. Furthermore WBC, plasma-cytokines,VCAM-1/ICAM-1, endothelin-1, Thromboxane B2, angiotensin 2, renin and PAI-1 are measured on an hourly basis up to 8 hours after endotoxin injection.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Renal failure
  • Heart failure
  • Lung disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413465

Contacts
Contact: Anne Sofie Andreasen, MD +45 3545 1616 sofie_andreasen@msn.com
Contact: Bente K Pedersen, Professor +45 3545 7621 bkp@rh.dk

Locations
Denmark
Intensiv Care Unit, Rigshospitalet, Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Anne Sofie Andreasen, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Anne Sofie Andreasen, MD Rigshospitalet, Denmark
  More Information

Study ID Numbers: RPF.sa.cim.rh.dk
Study First Received: December 18, 2006
Last Updated: December 18, 2006
ClinicalTrials.gov Identifier: NCT00413465  
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Renal Plasma Flow
Endotoxemia
Type 2 diabetes

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Bacteremia
Healthy
Toxemia
Inflammation
Sepsis
Diabetes Mellitus, Type 2
Endotoxemia
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 14, 2009