Please select the eligibility criteria that correspond to the clinical trial below.
Title: The AOT (Acridine Orange and Taurolidine) Trial: a Survey on Diagnosis and Prevention of Catheter-Related Infections in Patients on Home Parenteral Nutrition
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.


Options:
A: Inclusion Criteria:

1. End Stage Renal Disease 18 yrs or older.
2. CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
3. Expectation by Investigator that CVCD may be needed for up to 26 weeks.
4. Dialysis catheter is of three types a) single body with single entry and exit, b) single body with split ends, c) twin catheter with one catheter for removal of blood and another for return.
5. Kt/V \>1.1 or equivalent URR
6. Negative serum pregnancy unless surgically sterile or post menopausal for \>1yr.
7. Negative blood culture result from pre-enrollment blood sample draw.
8. Ability of patient to sign and understand the informed consent.
9. Most recent lab results don't indicate hypocalcemia (\<7mg/dL) or thrombocytopenia (\<20,000)
10. Avg. systolic blood pressure \>90 mmHg as measured during the most recent three dialysis treatments.
11. Lack of signs of current blood stream infection at the beginning of the prior three dialysis treatments.

Exclusion Criteria:

1. A known Heparin allergy or a history of type 2 (antibody mediated) Heparin-induced thrombocytopenia.
2. Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
3. Bloodstream infection,exit site infection or any infection requiring antibiotic use within 14 days of enrollment for any antibiotic listed in section 4.2.3 or within 30 days of enrollment for Vancomycin or any other antibiotic not listed in section 4.2.3 of the protocol
4. Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
5. Pregnant or breast feeding.
6. Documented allergy to sodium citrate, methylene blue, methyl/paraben and/or propyl paraben.
7. Documented chronic intrinsic coagulopathy evidenced by persistently and significantly elevated Prothrombin (INR\>3), Partial Thromboplastin Time (PTT\>60 seconds), or thrombocytopenia (platlet count \<20,000/mm).
8. Malignancy requiring chemotherapy or radiation treatment within 180 days of enrollment.
9. Documented requirement for \>5,000 units of Heparin per catheter lumen to maintain catheter patency (with decrease in blood flow demonstrated at 5,000 units per lumen Heparin catheter lock) with current catheter.
10. Contraindications to citrate or taking drugs that may interact with citrate.
11. Documented history of glucose-6-phosphate dehydrogenase deficiency (G6PD or Drug-induced methemoglobinemia).
12. Participation in another research study.
13. Co-morbidities, such as HIV, active hepatitis or recent transplants, that in the opinion of the Investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results and would make the subject inappropriate for entry into this study.
14. Unknown priming volume of catheter lumens.
15. Redness of over 1 cm diameter or pus around the catheter exit site.
B: 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)
C: Inclusion Criteria:

* First line chemotherapy for solid tumor with:
* Metastatic disease or
* Involved nodes or
* Unresectable tumor
* Indication for Implantable device for central venous access
* Potential survival \> 3 months
* ECOG performance status 0 to 2 (WHO)
* Age between 18 and 75 years.
* Social security guaranteed
* Normal laboratory assessments (platelets\> 100000/mm3, TP 60%, spontaneous TCA with M/T\<1.5, TGO and TGP \< 2xN, serum creatinin\<120µmol/l)
* Informed consent signed

Exclusion Criteria:

* Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria
* Acute infectious endocarditis
* History related with heparin allergy or thrombopenia due to heparin
* Uncontrolled high blood pressure (systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg)
* Hemorrhagic syndrome ongoing
* Patient with platelet inhibitors treatment
* Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level
* Patient with liver failure (TP\<60%) or renal insufficiency (creatinin clearance\< 20 ml/mn)
* Women with pregnancy and lactating Pathology-related criteria
* deep venous thrombosis history or pulmonary embolism (\< 6 months)
* Clinical suspicious of brain metastasis
D: Inclusion Criteria:

* Patients with Stage V chronic kidney disease preparing to start hemodialysis
* Exchange of an existing catheter to a cuffed, tunneled catheter OR planned vascular access with a cuffed, tunneled catheter
* CVC used for hemodialysis made of alcohol-resistant polymers ie. carbothane

Exclusion Criteria:

* Patients receiving catheters not made of alcohol resistant polymers
* Critically ill patients in ICU setting
* Patients with acute renal failure, who will likely not require prolonged vascular access ( ie. \> months)
* Patients with maturing fistulas/graft creation within 2 months
* Patients with planned antibiotic treatment courses lasting longer than 4 weeks from the date of new catheter insertion
* Patients receiving a new cuffed, tunneled catheter over a guide wire, if a fibrin sheath angioplasty was not performed after removing the previous dysfunctional catheter

Answer: B