Does a Central Venous Line Reduce Perioperative Fluid Administration?

NCT03985111 | Completed

• 3 other identifiers: 01259319/LO/0099252375
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Disorders

Keywords

perioperative care; perioperative blood pressure management; perioperative fluid management

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

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

• Mean dose of required vasopressor agents

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

• Use of cardiac output (flow-monitoring) equipment

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

• Length of hospital stay

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

Study Arms (2)

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

Interventions

Central Venous Catheter DEVICE

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

CVC inserted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Whipps Cross Hospital, Barts Health NHS Trust

London, E11 1NR, United Kingdom

Location

MeSH Terms

Interventions

Central Venous Catheters

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• David Melia, MBBS

  Barts & The London NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 13, 2019
• Study Start: May 1, 2019
• Primary Completion: May 19, 2020
• Study Completion: May 19, 2020
• Last Updated: May 29, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)