OpenAccessBelV2, Main, Exploration, bibRecord, 000736

Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial

Identifieur interne : 000736 ( Main/Exploration ); précédent : 000735; suivant : 000737

Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial

Auteurs : G. A. Goossens [Belgique] ; M. Jerome [Belgique] ; C. Janssens [Belgique] ; W. E. Peetermans [Belgique] ; S. Fieuws [Belgique] ; P. Moons [Belgique] ; J. Verschakelen [Belgique] ; K. Peerlinck [Belgique] ; M. Jacquemin [Belgique] ; M. Stas [Belgique]

Source :

Annals of oncology [ 0923-7534 ] ; 2013.

RBID : Pascal:13-0231338

Descripteurs français

Pascal (Inist)
- Etude comparative, Héparine, Anticoagulant, Accès veineux, Dispositif, Tumeur maligne, Homme, Malade, Randomisation, Cathéter, Infection, Chlorure de sodium, Etude de non infériorité, Essai de non-infériorité.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Anticoagulant, Catheter, Comparative study, Device, Heparin, Human, Infection, Malignant tumor, Non-inferiority trial, Patient, Randomization, Sodium chloride, Venous access.

Abstract

Background: Heparin has been used for years as a locking solution in totally implantable venous access devices. Normal saline (NS) might be a safe alternative for heparin. However, evidence of non-inferiority of NS versus heparin is lacking. Patients and methods: We randomly allocated 802 cancer patients with a newly inserted port either to heparin lock (300 U/3 ml) or to NS lock groups in a 1:1 assignment ratio. The primary outcome was the number of functional complications, which was defined as 'easy injection, impossible aspiration' at port access. Secondary outcomes included all functional problems and catheter-related bacteraemia. We hypothesised that NS locks do not cause more functional problems and catheter-related bacteraemia than heparin locks. Non-inferiority is established if the upper limit of the confidence interval (CI) for the relative risk of NS versus heparin is <1.4. Results: Three hundred and eighty-two patients from the NS group and 383 from the heparin lock group were included in the analysis. The incidence rate of our primary outcome (easy injection, impossible aspiration) was 3.70% (95% CI 2.91%-4.69%) and 3.92% (95% CI 3.09%-4.96%) of accesses in the NS and heparin groups, respectively. The relative risk was 0.94% (95% CI 0.67%-1.32%). Catheter-related bloodstream infection was 0.03 per 1000 catheter days in the NS group and 0.10 per 1000 catheter days in the heparin group. Conclusion: NS is a safe and effective locking solution in implantable ports if combined with a strict protocol for device insertion and maintenance.

Affiliations:

Belgique

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Le document en format XML

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<term>Human</term>
<term>Infection</term>
<term>Malignant tumor</term>
<term>Non-inferiority trial</term>
<term>Patient</term>
<term>Randomization</term>
<term>Sodium chloride</term>
<term>Venous access</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Etude comparative</term>
<term>Héparine</term>
<term>Anticoagulant</term>
<term>Accès veineux</term>
<term>Dispositif</term>
<term>Tumeur maligne</term>
<term>Homme</term>
<term>Malade</term>
<term>Randomisation</term>
<term>Cathéter</term>
<term>Infection</term>
<term>Chlorure de sodium</term>
<term>Etude de non infériorité</term>
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<front><div type="abstract" xml:lang="en">Background: Heparin has been used for years as a locking solution in totally implantable venous access devices. Normal saline (NS) might be a safe alternative for heparin. However, evidence of non-inferiority of NS versus heparin is lacking. Patients and methods: We randomly allocated 802 cancer patients with a newly inserted port either to heparin lock (300 U/3 ml) or to NS lock groups in a 1:1 assignment ratio. The primary outcome was the number of functional complications, which was defined as 'easy injection, impossible aspiration' at port access. Secondary outcomes included all functional problems and catheter-related bacteraemia. We hypothesised that NS locks do not cause more functional problems and catheter-related bacteraemia than heparin locks. Non-inferiority is established if the upper limit of the confidence interval (CI) for the relative risk of NS versus heparin is <1.4. Results: Three hundred and eighty-two patients from the NS group and 383 from the heparin lock group were included in the analysis. The incidence rate of our primary outcome (easy injection, impossible aspiration) was 3.70% (95% CI 2.91%-4.69%) and 3.92% (95% CI 3.09%-4.96%) of accesses in the NS and heparin groups, respectively. The relative risk was 0.94% (95% CI 0.67%-1.32%). Catheter-related bloodstream infection was 0.03 per 1000 catheter days in the NS group and 0.10 per 1000 catheter days in the heparin group. Conclusion: NS is a safe and effective locking solution in implantable ports if combined with a strict protocol for device insertion and maintenance.</div>
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Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial

Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial

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Abstract

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