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Study of Renal Blood Flow During Human Endotoxemia

NCT ID: NCT00413465

Last Updated: 2006-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Healthy Type 2 Diabetes Endotoxemia

Keywords

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Renal Plasma Flow Endotoxemia Type 2 diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Escherichia Coli Endotoxin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Type 2 diabetes

Exclusion Criteria

* Renal failure
* Heart failure
* Lung disease
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Anne Sofie Andreasen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Intensiv Care Unit, Rigshospitalet,

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anne Sofie Andreasen, MD

Role: CONTACT

Phone: +45 3545 1616

Email: [email protected]

Bente K Pedersen, Professor

Role: CONTACT

Phone: +45 3545 7621

Email: [email protected]

Other Identifiers

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RPF.sa.cim.rh.dk

Identifier Type: -

Identifier Source: org_study_id