| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Disorders | Device: Central Venous Catheter |
Show detailed description
| Study Type : | Observational |
| Actual Enrollment : | 40 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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? |
| Actual Study Start Date : | May 1, 2019 |
| Actual Primary Completion Date : | May 19, 2020 |
| Actual Study Completion Date : | May 19, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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No CVC inserted
Patients undergoing major elective colorectal resection without central venous catheter inserted pre-operatively
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CVC inserted
Patients undergoing major elective colorectal resection with a central venous catheter inserted pre-operatively
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Device: Central Venous Catheter
Insertion of a central venous catheter insertion pre-operatively (electively)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
| United Kingdom | |
| Whipps Cross Hospital, Barts Health NHS Trust | |
| London, United Kingdom, E11 1NR | |
| Study Director: | David Melia, MBBS | Barts & The London NHS Trust |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 7, 2019 | ||||
| First Posted Date | June 13, 2019 | ||||
| Last Update Posted Date | May 29, 2020 | ||||
| Actual Study Start Date | May 1, 2019 | ||||
| Actual Primary Completion Date | May 19, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Does a Central Venous Line Reduce Perioperative Fluid Administration? | ||||
| 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? | ||||
| Brief 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 | ||||
| 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.
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult patients, undergoing elective major colorectal resection, at a district general hospital in east London, UK. | ||||
| Condition | Colorectal Disorders | ||||
| Intervention | Device: Central Venous Catheter
Insertion of a central venous catheter insertion pre-operatively (electively)
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
40 | ||||
| Original Estimated Enrollment |
60 | ||||
| Actual Study Completion Date | May 19, 2020 | ||||
| Actual Primary Completion Date | May 19, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
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:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03985111 | ||||
| Other Study ID Numbers | 012593 19/LO/0099 ( Other Identifier: HREC ) 252375 ( Other Identifier: IRAS ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Barts & The London NHS Trust | ||||
| Study Sponsor | Barts & The London NHS Trust | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Barts & The London NHS Trust | ||||
| Verification Date | June 2019 | ||||