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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
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: December 18, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
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.

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

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Renal failure
  • Heart failure
  • Lung disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00413465     History of Changes
Other Study ID Numbers:
Study First Received: December 18, 2006
Last Updated: December 18, 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 processed this record on September 21, 2017