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Study of Renal Blood Flow During Human Endotoxemia

Primary Purpose

Healthy, Type 2 Diabetes, Endotoxemia

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Escherichia Coli Endotoxin

About this trial

This is an interventional prevention trial for Healthy focused on measuring Renal Plasma Flow, Endotoxemia, Type 2 diabetes

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy
Type 2 diabetes

Exclusion Criteria:

Renal failure
Heart failure
Lung disease

Sites / Locations

Intensiv Care Unit, Rigshospitalet,Recruiting

Outcomes

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,

Full Information

NCT ID

NCT00413465

First Posted

December 18, 2006

Last Updated

December 18, 2006

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00413465

Brief Title

Study of Renal Blood Flow During Human Endotoxemia

Official Title

Renal Plasma Flow During Experimental Human Endotoxemia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Type 2 Diabetes, Endotoxemia

Keywords

Renal Plasma Flow, Endotoxemia, Type 2 diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Escherichia Coli Endotoxin

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Type 2 diabetes Exclusion Criteria: Renal failure Heart failure Lung disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Sofie Andreasen, MD

Phone

+45 3545 1616

sofie_andreasen@msn.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bente K Pedersen, Professor

Phone

+45 3545 7621

bkp@rh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Sofie Andreasen, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intensiv Care Unit, Rigshospitalet,

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Sofie Andreasen, MD

12. IPD Sharing Statement

Learn more about this trial

Study of Renal Blood Flow During Human Endotoxemia

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