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.
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
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.
- Smith, RN, et al., 'Central venous catheters', BMJ 2013; 347:f6570
- Myles, PS, et al., 'Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery', N Engl J Med 2018; 378:24
- 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
- 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
- Gustafsson, UO, et al., 'Adherence to the Enhanced Recovery After Surgery Protocol and Outcomes After Colorectal Cancer Surgery', Arch Surg 2011; 146(5):571
- 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
- Conditions
- Colorectal Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Central Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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
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
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
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.
- First posted13 Jun 2019
- Study start1 May 2019
- Primary completion19 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Melia, MBBS, Study director, Barts & The London NHS Trust
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).
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03985111
- Acronym / sponsor ID
- 012593
- Conditions
- Colorectal Disorders
- Keywords
- perioperative care, perioperative blood pressure management, perioperative fluid management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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
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.
- Smith, RN, et al., 'Central venous catheters', BMJ 2013; 347:f6570
- Myles, PS, et al., 'Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery', N Engl J Med 2018; 378:24
- 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
- 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
- Gustafsson, UO, et al., 'Adherence to the Enhanced Recovery After Surgery Protocol and Outcomes After Colorectal Cancer Surgery', Arch Surg 2011; 146(5):571
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No CVC inserted | – | –Patients undergoing major elective colorectal resection without central venous catheter inserted pre-operatively |
| CVC inserted | – | Device: Central Venous CatheterPatients undergoing major elective colorectal resection with a central venous catheter inserted pre-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, undergoing elective major colorectal resection, at a district general hospital in east London, UK.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Venous CatheterInsertion of a central venous catheter insertion pre-operatively (electively) | Device | CVC inserted |
Primary outcome
Volume of intravenous fluid infused intra-operatively
Time frame: 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
Volume of intravenous fluid infused post-operatively
Time frame: 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
5 secondary outcomes
Length of Intensive Care Unit Stay
Time frame: 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
Time frame: From induction of anaesthesia until the end of the 12th post-operative hour
Mean dose of required vasopressor agents
Time frame: From induction of anaesthesia until the end of the 12th post-operative hour
Use of cardiac output (flow-monitoring) equipment
Time frame: From induction of anaesthesia until the end of the 12th post-operative hour
Length of hospital stay
Time frame: From the day of the procedure until discharge from the hospital (and until the expected end of study on 30th April 2020)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Melia, MBBS study director
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
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.