Trisodium citrate 4% versus heparin as a catheter lock for non-tunneled hemodialysis catheters in critically ill patients: a multicenter, randomized clinical trial.

Acute renal failure Catheters Citra-Lock Critical illness Hemodialysis Heparin

Journal

Annals of intensive care
ISSN: 2110-5820
Titre abrégé: Ann Intensive Care
Pays: Germany
ID NLM: 101562873

Informations de publication

Date de publication:
01 Jul 2019
Historique:
received: 31 03 2019
accepted: 24 06 2019
entrez: 3 7 2019
pubmed: 3 7 2019
medline: 3 7 2019
Statut: epublish

Résumé

Non-tunneled hemodialysis catheters are currently used for critically ill patients with acute kidney injury requiring extracorporeal renal replacement therapy. Strategies to prevent catheter dysfunction and infection with catheter locks remain controversial. In a multicenter, randomized, controlled, double-blind trial, we compared two strategies for catheter locking of non-tunneled hemodialysis catheters, namely trisodium citrate at 4% (intervention group) versus unfractionated heparin (control group), in patients aged 18 years or older admitted to the intensive care unit and in whom a first non-tunneled hemodialysis catheter was to be inserted by the jugular or femoral vein. The primary endpoint was length of event-free survival of the first non-tunneled hemodialysis catheter. Secondary endpoints were: rate of fibrinolysis, incidence of catheter dysfunction and incidence of catheter-related bloodstream infection (CRBSI), all per 1000 catheter-days; number of hemorrhagic events requiring transfusion, length of stay in intensive care and in hospital; 28-day mortality. Overall, 396 randomized patients completed the trial: 199 in the citrate group and 197 in the heparin group. There was no significant difference in baseline characteristics between groups. The duration of event-free survival of the first non-tunneled hemodialysis catheter was not significantly different between groups: 7 days (IQR 3-10) in the citrate group and 5 days (IQR 3-11) in the heparin group (p = 0.51). Rates of catheter thrombosis, CRBSI, and adverse events were not statistically different between groups. In critically ill patients, there was no significant difference in the duration of event-free survival of the first non-tunneled hemodialysis catheter between trisodium citrate 4% and heparin as a locking solution. Catheter thrombosis, catheter-related infection, and adverse events were not statistically different between the two groups. Trial registration Registered with Clinicaltrials.gov under the number NCT01962116. Registered 14 October 2013.

Sections du résumé

BACKGROUND BACKGROUND
Non-tunneled hemodialysis catheters are currently used for critically ill patients with acute kidney injury requiring extracorporeal renal replacement therapy. Strategies to prevent catheter dysfunction and infection with catheter locks remain controversial.
METHODS METHODS
In a multicenter, randomized, controlled, double-blind trial, we compared two strategies for catheter locking of non-tunneled hemodialysis catheters, namely trisodium citrate at 4% (intervention group) versus unfractionated heparin (control group), in patients aged 18 years or older admitted to the intensive care unit and in whom a first non-tunneled hemodialysis catheter was to be inserted by the jugular or femoral vein. The primary endpoint was length of event-free survival of the first non-tunneled hemodialysis catheter. Secondary endpoints were: rate of fibrinolysis, incidence of catheter dysfunction and incidence of catheter-related bloodstream infection (CRBSI), all per 1000 catheter-days; number of hemorrhagic events requiring transfusion, length of stay in intensive care and in hospital; 28-day mortality.
RESULTS RESULTS
Overall, 396 randomized patients completed the trial: 199 in the citrate group and 197 in the heparin group. There was no significant difference in baseline characteristics between groups. The duration of event-free survival of the first non-tunneled hemodialysis catheter was not significantly different between groups: 7 days (IQR 3-10) in the citrate group and 5 days (IQR 3-11) in the heparin group (p = 0.51). Rates of catheter thrombosis, CRBSI, and adverse events were not statistically different between groups.
CONCLUSIONS CONCLUSIONS
In critically ill patients, there was no significant difference in the duration of event-free survival of the first non-tunneled hemodialysis catheter between trisodium citrate 4% and heparin as a locking solution. Catheter thrombosis, catheter-related infection, and adverse events were not statistically different between the two groups. Trial registration Registered with Clinicaltrials.gov under the number NCT01962116. Registered 14 October 2013.

Identifiants

pubmed: 31264073
doi: 10.1186/s13613-019-0553-4
pii: 10.1186/s13613-019-0553-4
pmc: PMC6603108
doi:

Banques de données

ClinicalTrials.gov
['NCT01962116']

Types de publication

Journal Article

Langues

eng

Pagination

75

Subventions

Organisme : Centre Hospitalier Universitaire de Dijon
ID : AAP 2012

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Auteurs

Jean-Pierre Quenot (JP)

Service de Médecine Intensive-Réanimation, Centre Hospitalier Universitaire Dijon Bourgogne, 14 rue Paul Gaffarel, B.P 77908, 21079, Dijon Cedex, France. jean-pierre.quenot@chu-dijon.fr.
Université Bourgogne Franche-Comté, Lipness Team UMR 1231 et LabExLipSTIC, 21000, Dijon, France. jean-pierre.quenot@chu-dijon.fr.
INSERM, CIC 1432, module Epidémiologie Clinique, 21000, Dijon, France. jean-pierre.quenot@chu-dijon.fr.
CHU de Dijon, Centre d'Investigation Clinique, module Epidémiologie Clinique/Essais cliniques, 21000, Dijon, France. jean-pierre.quenot@chu-dijon.fr.

Julie Helms (J)

CHRU de Strasbourg, Nouvel Hôpital Civil, Service de Réanimation Médicale, 67000, Strasbourg, France.
Université de Strasbourg, UMR 1260, régénérative nanomédicine, FMTS, 67 000, Strasbourg, France.

Abderrahmane Bourredjem (A)

INSERM, CIC 1432, module Epidémiologie Clinique, 21000, Dijon, France.
CHU de Dijon, Centre d'Investigation Clinique, module Epidémiologie Clinique/Essais cliniques, 21000, Dijon, France.

Auguste Dargent (A)

Service de Médecine Intensive-Réanimation, Centre Hospitalier Universitaire Dijon Bourgogne, 14 rue Paul Gaffarel, B.P 77908, 21079, Dijon Cedex, France.
Université Bourgogne Franche-Comté, Lipness Team UMR 1231 et LabExLipSTIC, 21000, Dijon, France.

Ferhat Meziani (F)

CHRU de Strasbourg, Nouvel Hôpital Civil, Service de Réanimation Médicale, 67000, Strasbourg, France.
Université de Strasbourg, UMR 1260, régénérative nanomédicine, FMTS, 67 000, Strasbourg, France.

Julio Badie (J)

CH de Belfort-Montbéliard, Service de Réanimation Polyvalente, 90000, Belfort, France.

Gilles Blasco (G)

CHU de Besançon, Service de Réanimation Chirurgicale, 25000, Besançon, France.

Gaël Piton (G)

CHU de Besançon, Service de Réanimation Médicale, 25000, Besançon, France.
Université de Franche-Comté, EA 3920, 25000, Besançon, France.

Gilles Capellier (G)

CHU de Besançon, Service de Réanimation Médicale, 25000, Besançon, France.
Université de Franche-Comté, EA 3920, 25000, Besançon, France.

Chaouki Mezher (C)

CH Belfort-Montbéliard, Service de Réanimation Polyvalente, 25200, Montbéliard, France.

Jean-Michel Rebibou (JM)

CHU Dijon Bourgogne, Service de Néphrologie, 21000, Dijon, France.

Abdelouaid Nadji (A)

CHU Dijon Bourgogne, Service de Réanimation Neuro-Traumatologique, 21000, Dijon, France.

Thomas Crepin (T)

CHU de Besançon, Service de Soins intensifs Néphrologie, 25000, Besançon, France.

Saber Davide Barbar (SD)

CHU de Nîmes, Service de Réanimation Médicale, 30 000, Nîmes, France.

Camille Fleck (C)

CHU Dijon Bourgogne, Délégation à la Recherche Clinique et à l'Innovation (DRCI), 21000, Dijon, France.

Amélie Cransac (A)

Département de Pharmacie, CHU Dijon Bourgogne, 21000, Dijon, France.
Université de Bourgogne Franche-Comté, LNC-UMR 1231, 21000, Dijon, France.

Mathieu Boulin (M)

Département de Pharmacie, CHU Dijon Bourgogne, 21000, Dijon, France.
Université de Bourgogne Franche-Comté, LNC-UMR 1231, 21000, Dijon, France.

Christine Binquet (C)

INSERM, CIC 1432, module Epidémiologie Clinique, 21000, Dijon, France.
CHU de Dijon, Centre d'Investigation Clinique, module Epidémiologie Clinique/Essais cliniques, 21000, Dijon, France.

Agnès Soudry-Faure (A)

CHU Dijon Bourgogne, Unité de Soutien Méthodologique à la Recherche (USMR), 21000, Dijon, France.

Rémi Bruyère (R)

CH de Bourg en Bresse, Service de Réanimation polyvalente, 01000, Bourg en Bresse, France.

Classifications MeSH