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Study of Renal Blood Flow During Human Endotoxemia

Renal Plasma Flow During Experimental Human Endotoxemia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00413465
Enrollment
32
Registered
2006-12-19
Start date
2006-11-30
Completion date
2007-12-31
Last updated
2006-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotoxemia, Healthy, Type 2 Diabetes

Keywords

Renal Plasma Flow, Endotoxemia, Type 2 diabetes

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.

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.

Interventions

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Type 2 diabetes

Exclusion criteria

* Renal failure * Heart failure * Lung disease

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Mean arterial pressure, Heart rate, Oxygen saturation, Body temperature,

Countries

Denmark

Contacts

Primary ContactAnne Sofie Andreasen, MD
sofie_andreasen@msn.com+45 3545 1616
Backup ContactBente K Pedersen, Professor
bkp@rh.dk+45 3545 7621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026