Study of Renal Blood Flow During Human Endotoxemia

December 18, 2006 updated by: Rigshospitalet, Denmark

Renal Plasma Flow During Experimental Human Endotoxemia

The purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bente K Pedersen, Professor
  • Phone Number: +45 3545 7621
  • Email: bkp@rh.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Intensiv Care Unit, Rigshospitalet,
        • Principal Investigator:
          • Anne Sofie Andreasen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy
  • Type 2 diabetes

Exclusion Criteria:

  • Renal failure
  • Heart failure
  • Lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Anne Sofie Andreasen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

December 18, 2006

First Submitted That Met QC Criteria

December 18, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

December 19, 2006

Last Update Submitted That Met QC Criteria

December 18, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPF.sa.cim.rh.dk

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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