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NCT00413465 Clinical Trial

Study of Renal Blood Flow During Human Endotoxemia

Healthy Clinical Trial

Official title:
Renal Plasma Flow During Experimental Human Endotoxemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00413465
Other study ID # RPF.sa.cim.rh.dk
Secondary ID
Status Recruiting
Phase N/A
First received December 18, 2006
Last updated December 18, 2006
Start date November 2006
Est. completion date December 2007

Study information
Verified date December 2006
Source Rigshospitalet, Denmark
Contact Anne Sofie Andreasen, MD
Phone +45 3545 1616
Email sofie_andreasen@msn.com
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 32
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria:

- Healthy

- Type 2 diabetes

Exclusion Criteria:

- Renal failure

- Heart failure

- Lung disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Escherichia Coli Endotoxin

Locations
Country Name City State
Denmark Intensiv Care Unit, Rigshospitalet, Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,
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