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Does a Central Venous Line Reduce Perioperative Fluid Administration?

28 mai 2020 mis à jour par: Barts & The London NHS Trust

In High Risk Patients Undergoing Elective Colorectal Resection, Does Routine Placement of a Central Venous Catheter Reduce Peri-operative Fluid Administration in Theatre and the Critical Care Unit?

'Hypothesis-generating' study to assess whether the presence of a central venous line significantly affects the volumes of fluid infused perioperatively in major elective colorectal surgery

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

There are several indications for elective central venous cannulation in major colorectal surgery, particularly in those at a higher risk of morbidity and mortality. These include: the ability to infuse certain vasoactive medications, monitor central venous pressure, allow for frequent blood sampling, and provide a route of access for total parenteral nutrition(1). Furthermore, there has been a great deal of recent interest in whether there are improved outcomes with restrictive as opposed to liberal fluid therapy in major abdominal surgery(2), and, similarly, with individualised, rather than generic, blood pressure management in major surgery(3). However, there have been no major studies to date examining whether the simple act of electively inserting a central venous catheter prior to the start of surgery influences the volume of fluid infused and the use of vasopressors perioperatively.

The RELIEF trial reported that modestly liberal perioperative fluid regimens conferred no greater disability-free survival benefit over restrictive regimens, but are likely to reduce rates of acute kidney injury(2). This contrasts with the restrictive protocols championed by various Enhanced Recovery After Surgery (ERAS) programs(4). Previous works have suggested that not only does adherence to ERAS principles lead to superior patient outcomes, but some have gone further in identifying restriction of intravenous fluids perioperatively to be one of the few interventions that independently predicts a better outcome(5). One of the advantages of central venous catheterisation is the ability to administer drugs in smaller volumes of fluid. Therefore, given the intensity of the debate surrounding restrictive and liberal regimens, it should be investigated whether the availability of central venous access impacts upon the volumes of fluid infused.

Furthermore, central venous catheterisation is unlikely just to have an impact via the avoidance of inadvertent larger volume infusion, which is sometimes seen with drug administration through a peripheral line. The RELIEF trial reported that the patient cohort managed with a restrictive fluid regimen were more likely to receive vasopressor support, compared with those receiving a liberal regimen(2). The presence of a central venous catheter enables the use of potent vasopressor agents, such as noradrenaline, which will further influence fluid administration, by introducing a second therapeutic option for correcting perioperative hypotension. The importance of 'tight' blood pressure control has been demonstrated by the INPRESS trial, which showed a reduction in post-operative organ dysfunction with individualised blood pressure management, over standard management strategies(3). This is of particular importance, as evidence has shown that cardiac output-directed fluid therapy should not lead to 'excessive fluid administration, but may lead to a more individualised approach to achieving the correct dose of fluid'(6), and may require concomitant use of vasoactive agents.

Thus, the investigators have set out to investigate whether the elective insertion of a central venous catheter prior to the start of major colorectal surgery, influences the volumes, and types, of fluid infused, as well as the use and mean dose of vasopressor agents, intra-operatively and for the first 12 hours post-operatively.

  1. Smith, RN, et al., 'Central venous catheters', BMJ 2013; 347:f6570
  2. Myles, PS, et al., 'Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery', N Engl J Med 2018; 378:24
  3. Futier, E, et al., 'Effect of Individualised vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery', JAMA 2017; 318(14):1346
  4. Feldheiser, A, et al., 'Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice', Acta Anaesthesiologica Scandinavia 2016, 60:289
  5. Gustafsson, UO, et al., 'Adherence to the Enhanced Recovery After Surgery Protocol and Outcomes After Colorectal Cancer Surgery', Arch Surg 2011; 146(5):571
  6. Pearse, RM, et al., 'Effect of a Perioperative Cardiac Output- Guided Haemodynamic Therapy Algorithm on Outcomes Following Major Gastrointestinal Surgery', JAMA 2014; 311(21):2181

Type d'étude

Observationnel

Inscription (Réel)

40

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • London, Royaume-Uni, E11 1NR
        • Whipps Cross Hospital, Barts Health NHS Trust

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adult patients, undergoing elective major colorectal resection, at a district general hospital in east London, UK.

La description

Inclusion Criteria:

The inclusion criteria will be all adult patients presenting for elective major colorectal surgery (resection), whom are to be electively admitted to critical care directly from theatre.

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients undergoing emergency surgery
  • Those not admitted electively to critical care directly from theatre
  • Those patients that do not undergo any bowel resection
  • Patients in whom central venous catheter insertion is as an emergency peri- operatively
  • Patients refusing/unable to give valid informed consent

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
No CVC inserted
Patients undergoing major elective colorectal resection without central venous catheter inserted pre-operatively
CVC inserted
Patients undergoing major elective colorectal resection with a central venous catheter inserted pre-operatively
Insertion of a central venous catheter insertion pre-operatively (electively)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Volume of intravenous fluid infused intra-operatively
Délai: Intra-operatively (from induction to leaving theatre)
To assess whether the presence of a central venous catheter influences the volume of intravenous fluid infused intra-operatively
Intra-operatively (from induction to leaving theatre)
Volume of intravenous fluid infused post-operatively
Délai: The first 12 hours post-operatively (commencing from the arrival on the critical care unit, until the end of the 12th post-operative hour)
To assess whether the presence of a central venous catheter influences the volume of intravenous fluid infused post-operatively
The first 12 hours post-operatively (commencing from the arrival on the critical care unit, until the end of the 12th post-operative hour)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Length of Intensive Care Unit Stay
Délai: From admission to intensive care, until stepdown to the ward (and until the expected end of study on 30th April 2020)
Does the presence of a central venous catheter alter length of post-operative stay on the Intensive Care Unit
From admission to intensive care, until stepdown to the ward (and until the expected end of study on 30th April 2020)
Volume of blood product infused peri-operatively
Délai: From induction of anaesthesia until the end of the 12th post-operative hour
To assess whether the presence of a central venous catheter influences the volume of blood products infused peri-operatively
From induction of anaesthesia until the end of the 12th post-operative hour
Mean dose of required vasopressor agents
Délai: From induction of anaesthesia until the end of the 12th post-operative hour
To assess whether the presence of a central venous catheter influences the mean dose of any required vasopressor agents peri-operatively
From induction of anaesthesia until the end of the 12th post-operative hour
Use of cardiac output (flow-monitoring) equipment
Délai: From induction of anaesthesia until the end of the 12th post-operative hour
To assess whether the presence of a central venous catheter, and any ensuing fluid and blood pressure management strategies, influence the use of cardiac output monitoring equipment peri-operatively
From induction of anaesthesia until the end of the 12th post-operative hour
Length of hospital stay
Délai: From the day of the procedure until discharge from the hospital (and until the expected end of study on 30th April 2020)
To assess whether the presence of a central venous catheter influences the total post-operative length of stay
From the day of the procedure until discharge from the hospital (and until the expected end of study on 30th April 2020)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: David Melia, MBBS, Barts & The London NHS Trust

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mai 2019

Achèvement primaire (Réel)

19 mai 2020

Achèvement de l'étude (Réel)

19 mai 2020

Dates d'inscription aux études

Première soumission

7 juin 2019

Première soumission répondant aux critères de contrôle qualité

12 juin 2019

Première publication (Réel)

13 juin 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2020

Dernière vérification

1 juin 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 012593
  • 19/LO/0099 (Autre identifiant: HREC)
  • 252375 (Autre identifiant: IRAS)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

At this stage there is no plan to make IPD available, and certainly no such intention has been discussed with the relevant ethical and review boards (HREC/HRA).

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Troubles colorectaux

Essais cliniques sur Central Venous Catheter

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