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Study of Renal Blood Flow During Human Endotoxemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413465
First Posted: December 19, 2006
Last Update Posted: December 19, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Renal Plasma Flow During Experimental Human Endotoxemia

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00413465     History of Changes
Other Study ID Numbers: RPF.sa.cim.rh.dk
First Submitted: December 18, 2006
First Posted: December 19, 2006
Last Update Posted: December 19, 2006
Last Verified: December 2006

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Endotoxemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes