Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Renal Blood Flow During Human Endotoxemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00413465
First received: December 18, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 18, 2006
December 18, 2006
November 2006
Not Provided
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
Same as current
No Changes Posted
Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,
Same as current
Not Provided
Not Provided
 
Study of Renal Blood Flow During Human Endotoxemia
Renal Plasma Flow During Experimental Human Endotoxemia

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Healthy
  • Type 2 Diabetes
  • Endotoxemia
Drug: Escherichia Coli Endotoxin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
December 2007
Not Provided

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Renal failure
  • Heart failure
  • Lung disease
Male
25 Years to 80 Years
Yes
Contact: Anne Sofie Andreasen, MD +45 3545 1616 sofie_andreasen@msn.com
Contact: Bente K Pedersen, Professor +45 3545 7621 bkp@rh.dk
Denmark
 
NCT00413465
RPF.sa.cim.rh.dk
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Anne Sofie Andreasen, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
December 2006

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