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Does a Central Venous Line Reduce Perioperative Fluid Administration?

28 de maio de 2020 atualizado por: 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

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

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

Tipo de estudo

Observacional

Inscrição (Real)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • London, Reino Unido, E11 1NR
        • Whipps Cross Hospital, Barts Health NHS Trust

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Volume of intravenous fluid infused intra-operatively
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Length of Intensive Care Unit Stay
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: David Melia, MBBS, Barts & The London NHS Trust

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de maio de 2019

Conclusão Primária (Real)

19 de maio de 2020

Conclusão do estudo (Real)

19 de maio de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

7 de junho de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de junho de 2019

Primeira postagem (Real)

13 de junho de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de maio de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2020

Última verificação

1 de junho de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 012593
  • 19/LO/0099 (Outro identificador: HREC)
  • 252375 (Outro identificador: IRAS)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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).

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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