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Colorectal DisordersNCT03985111

Does a Central Venous Line Reduce Perioperative Fluid Administration?

An observational study of Colorectal Disorders, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

'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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Disorders
What is being tested?
Central Venous Catheter
Type of treatment
Medical device
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
1 May 2019to 19 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Whipps Cross Hospital, Barts Health NHS Trust

    London, E11 1NR

Other trials in United Kingdom

About this study

Official title: 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

Read the detailed description

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
Being tested
Central Venous Catheter
Keywords
perioperative care, perioperative blood pressure management, perioperative fluid management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Central Venous CatheterDevice

    Insertion of a central venous catheter insertion pre-operatively (electively)

Study groups in NCT03985111
Study groupRoleWhat they receive
No CVC insertedPatients undergoing major elective colorectal resection without central venous catheter inserted pre-operatively
CVC insertedPatients undergoing major elective colorectal resection with a central venous catheter inserted pre-operatively
Receives: Device: Central Venous Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of intravenous fluid infused intra-operatively

    To assess whether the presence of a central venous catheter influences the volume of intravenous fluid infused intra-operatively

    Measured: Intra-operatively (from induction to leaving theatre)

  2. Volume of intravenous fluid infused post-operatively

    To assess whether the presence of a central venous catheter influences the volume of intravenous fluid infused post-operatively

    Measured: The first 12 hours post-operatively (commencing from the arrival on the critical care unit, until the end of the 12th post-operative hour)

Secondary outcomes (5)
  1. Length of Intensive Care Unit Stay

    Does the presence of a central venous catheter alter length of post-operative stay on the Intensive Care Unit

    Measured: From admission to intensive care, until stepdown to the ward (and until the expected end of study on 30th April 2020)

  2. Volume of blood product infused peri-operatively

    To assess whether the presence of a central venous catheter influences the volume of blood products infused peri-operatively

    Measured: From induction of anaesthesia until the end of the 12th post-operative hour

  3. Mean dose of required vasopressor agents

    To assess whether the presence of a central venous catheter influences the mean dose of any required vasopressor agents peri-operatively

    Measured: From induction of anaesthesia until the end of the 12th post-operative hour

  4. Use of cardiac output (flow-monitoring) equipment

    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

    Measured: From induction of anaesthesia until the end of the 12th post-operative hour

  5. Length of hospital stay

    To assess whether the presence of a central venous catheter influences the total post-operative length of stay

    Measured: From the day of the procedure until discharge from the hospital (and until the expected end of study on 30th April 2020)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2019
  2. Study start1 May 2019
  3. Primary completion19 May 2020
  4. Study completion19 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03985111
Sponsor's protocol ID
012593
Other IDs
19/LO/0099, 252375
Status last verified
Jun 2019
First submitted
7 Jun 2019
Last updated
29 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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).

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Disorders, run by Barts & The London NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume of intravenous fluid infused intra-operatively (time frame: Intra-operatively (from induction to leaving theatre)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2020.

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