Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321165
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2006-05-02
Brief Title:
The AOT Acridine Orange and Taurolidine Trial
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The AOT Acridine Orange and Taurolidine Trial a Survey on Diagnosis and Prevention of Catheter-Related Infections in Patients on Home Parenteral Nutrition
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total parenteral intravenous nutrition in the home setting Home TPN or HPN is a life saving strategy in patients who suffer from severe intestinal failure Unfortunately this treatment modality remains complicated by the development of frequent infectious complications This especially relates to the device that is used to establish venous access mostly a catheter Hickman-Broviac type or a port-a-cath
Taurolodine is an antimicrobial agent without any known side effects or resistance-related problems that holds promise as an effective antibiotic lock solution to prevent catheter infections as demonstrated recently in a pilot study in HPN patients Jurewitsch 2005
In addition recently a test has been described which may enable to confirm a suspected diagnosis of central line infection within one hour the so-called Acridine Orange Leukocyte Cytospin test AOLC Bong 2003 For this test blood that is drawn from the central line is stained with the fluorescent dye acridine orange Next microscopic evaluation for the presence of micro-organisms takes place Implementation of this test might enable to start treatment of the infection and prevent unnecessary removal of non-infected central lines without the necessity to several days wait for culture results
Taurolodine is an antimicrobial agent without any known side effects or resistance-related problems that holds promise as an effective antibiotic lock solution to prevent catheter infections as demonstrated recently in a pilot study in HPN patients Jurewitsch 2005
In addition recently a test has been described which may enable to confirm a suspected diagnosis of central line infection within one hour the so-called Acridine Orange Leukocyte Cytospin test AOLC Bong 2003 For this test blood that is drawn from the central line is stained with the fluorescent dye acridine orange Next microscopic evaluation for the presence of micro-organisms takes place Implementation of this test might enable to start treatment of the infection and prevent unnecessary removal of non-infected central lines without the necessity to several days wait for culture results
Detailed Description:
Two hypotheses will be tested in the AOT trial
1 The use of taurolidine as an antibiotic lock 5 mL to flush the central line after infusing the TPN formulation when compared to the present use of heparin solution 5 mL 150 EmL decreases the rate of catheter-related infections in HPN patients
2 Implementation of the acridine orange staining test allows an earlier diagnosis or rejection of this diagnosis compared to culture results Importantly in the present trial the results of this test will not be used for treatment decisions
To this end patients who are admitted to the clinical ward because of suspected central line infection mostly because of fever andor chills will be treated according to the current protocol for catheter sepsis after obtaining central line and peripheral blood cultures This protocol includes the administration of medicinase through the central line and iv antibiotics peripherally After obtaining informed consent in addition 5 cc of EDTA blood will be drawn from the central line to perform within 24 hours the acridine orange cytospin staining test and a Gram stain These results will than be compared to the culture results Based on culture results the antibiotics will be tailored
If the patient recovers and TPN administration can be restarted randomisation between heparin lock 5 mL 150 EmL versus taurolidine lock solution 2 5 mL will take place In case the catheter has to be removed because of ongoing or recurrent sepsis randomisation takes place after a new central line has been placed and the patient continues on TPN
A new episode of proven catheter sepsis is considered as the primary end-point
1 The use of taurolidine as an antibiotic lock 5 mL to flush the central line after infusing the TPN formulation when compared to the present use of heparin solution 5 mL 150 EmL decreases the rate of catheter-related infections in HPN patients
2 Implementation of the acridine orange staining test allows an earlier diagnosis or rejection of this diagnosis compared to culture results Importantly in the present trial the results of this test will not be used for treatment decisions
To this end patients who are admitted to the clinical ward because of suspected central line infection mostly because of fever andor chills will be treated according to the current protocol for catheter sepsis after obtaining central line and peripheral blood cultures This protocol includes the administration of medicinase through the central line and iv antibiotics peripherally After obtaining informed consent in addition 5 cc of EDTA blood will be drawn from the central line to perform within 24 hours the acridine orange cytospin staining test and a Gram stain These results will than be compared to the culture results Based on culture results the antibiotics will be tailored
If the patient recovers and TPN administration can be restarted randomisation between heparin lock 5 mL 150 EmL versus taurolidine lock solution 2 5 mL will take place In case the catheter has to be removed because of ongoing or recurrent sepsis randomisation takes place after a new central line has been placed and the patient continues on TPN
A new episode of proven catheter sepsis is considered as the primary end-point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None