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Does a Central Venous Line Reduce Perioperative Fluid Administration?

28 mei 2020 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Werkelijk)

40

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • London, Verenigd Koninkrijk, E11 1NR
        • Whipps Cross Hospital, Barts Health NHS Trust

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Volume of intravenous fluid infused intra-operatively
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Length of Intensive Care Unit Stay
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: David Melia, MBBS, Barts & The London NHS Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2019

Primaire voltooiing (Werkelijk)

19 mei 2020

Studie voltooiing (Werkelijk)

19 mei 2020

Studieregistratiedata

Eerst ingediend

7 juni 2019

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2019

Eerst geplaatst (Werkelijk)

13 juni 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2020

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2020

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 012593
  • 19/LO/0099 (Andere identificatie: HREC)
  • 252375 (Andere identificatie: IRAS)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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).

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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