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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Renal Plasma Flow During Experimental Human Endotoxemia

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 21, 2013