Study of Renal Blood Flow During Human Endotoxemia

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. Identifier: NCT00413465
Recruitment Status : Unknown
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : December 19, 2006
Last Update Posted : December 19, 2006
Information provided by:
Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Type 2 Diabetes Endotoxemia Drug: Escherichia Coli Endotoxin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Renal Plasma Flow During Experimental Human Endotoxemia
Study Start Date : November 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Renal failure
  • Heart failure
  • Lung disease

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 identifier (NCT number): NCT00413465

Contact: Anne Sofie Andreasen, MD +45 3545 1616
Contact: Bente K Pedersen, Professor +45 3545 7621

Intensiv Care Unit, Rigshospitalet, Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Anne Sofie Andreasen, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Anne Sofie Andreasen, MD Rigshospitalet, Denmark Identifier: NCT00413465     History of Changes
Other Study ID Numbers:
First Posted: December 19, 2006    Key Record Dates
Last Update Posted: December 19, 2006
Last Verified: December 2006

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes