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Does a Central Venous Line Reduce Perioperative Fluid Administration?

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ClinicalTrials.gov Identifier: NCT03985111
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

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

Condition or disease Intervention/treatment
Colorectal Disorders Device: Central Venous Catheter

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 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
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Group/Cohort Intervention/treatment
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
Device: Central Venous Catheter
Insertion of a central venous catheter insertion pre-operatively (electively)




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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) ]
    Does the presence of a central venous catheter alter length of post-operative stay on the Intensive Care Unit

  2. Volume of blood product infused peri-operatively [ Time Frame: 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

  3. Mean dose of required vasopressor agents [ Time Frame: 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

  4. Use of cardiac output (flow-monitoring) equipment [ Time Frame: 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

  5. 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) ]
    To assess whether the presence of a central venous catheter influences the total post-operative length of stay



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

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985111


Contacts
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Contact: David Melia, MBBS +442085395522 ext 5825 DavidJohn.Melia@bartshealth.nhs.uk
Contact: Benjamin Milne, MBBS +442085395522 ext 5825 benjamin.milne1@nhs.net

Locations
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United Kingdom
Whipps Cross Hospital, Barts Health NHS Trust Recruiting
London, United Kingdom, E11 1NR
Contact: David Melia, MBBS    +442085395522 ext 5825    DavidJohn.Melia@bartshealth.nhs.uk   
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
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Study Director: David Melia, MBBS Barts & The London NHS Trust

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03985111     History of Changes
Other Study ID Numbers: 012593
19/LO/0099 ( Other Identifier: HREC )
252375 ( Other Identifier: IRAS )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barts & The London NHS Trust:
perioperative care
perioperative blood pressure management
perioperative fluid management