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NCT Number: NCT00321165

The AOT (Acridine Orange and Taurolidine) Trial

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.

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Key information

Conditions

Parenteral Nutrition Hyperphagia Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Signs and Symptoms, Digestive Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Gastroenterology and Hepatology clinical ward

Nijmegen, 6500 HB, Netherlands

About this study

Two hypotheses will be tested in the AOT trial:

  • 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 E/mL) decreases the rate of catheter-related infections in HPN patients
  • 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 and/or 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 i.v. 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 E/mL) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent
  • patient on home TPN with central line (Hickman or Porth-a-cath)
  • suspected central line infection (acridine orange test)
  • proven central line infection (randomisation tauroline vs heparin)

Exclusion criteria

  • no informed consent
  • patient on home TPN with arteriovenous fistula (shunt)

Treatment and study plan

taurolidine

Drug

Primary outcomes

  1. time between episodes of central line infection in one patient

Secondary outcomes

  1. outcome of acridine orange staining test compared to culture results

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The AOT (Acridine Orange and Taurolidine) Trial: a Survey on Diagnosis and Prevention of Catheter-Related Infections in Patients on Home Parenteral Nutrition

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 3, 2006
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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