Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy

This study has been completed.
Sponsor:
Collaborators:
Counties Manukau District Health Board
Waitemata District Health Board
Information provided by (Responsible Party):
SACS, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT00911391
First received: May 28, 2009
Last updated: November 25, 2011
Last verified: November 2011
  Purpose

Perioperative fluid management has been historically dictated by outdated, contradictory concepts. Excessive or inadequate fluid administration around surgery is deleterious and hence goal-directed fluid therapy using Oesophageal Doppler-derived cardiac indices is preferable to optimize tissue perfusion. Previous studies in this area have been hampered by lack of standardization in other aspects of perioperative care and none have explored the impact of individualized fluid therapy on post-operative fatigue.The investigators proposed a study involving 80 patients having open/ laparoscopic colonic surgery to investigate the effect of Oesophageal Doppler guided fluid administration intraoperatively compared to current best practice of fluid restriction. The investigators have an optimized peri-operative care pathway established at the Manukau Surgical Centre (MSC), Middlemore Hospital. All patients will be cared for under the Enhanced Recovery After Surgery (ERAS) multimodal care plan therefore ensuring that all other aspects of care besides intraoperative fluid administration remain homogenous. Outcomes will include post-operative recovery, clinical outcomes as well as physiological data with follow-up to 30 days.


Condition Intervention Phase
Colorectal Cancer
Colectomy
Surgery
Perioperative Care
Device: Oesophageal Doppler
Procedure: Intraoperative fluid restriction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Double-Blinded, Randomised Controlled Trial of Doppler-Optimised Fluid Balance in Elective Colectomy Within an ERAS Protocol

Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • Post-operative functional recovery [ Time Frame: 7 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Perioperative Complications [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    As defined using trial by Buzby et al Am J Nutr 1989 and graded according to Clavien-Dindo classification


Enrollment: 85
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluid restriction
Current best practice of intraoperative fluid restriction
Procedure: Intraoperative fluid restriction
Current best practice of avoiding fluid overload by intraoperative fluid restriction
Experimental: Oesophageal Doppler
Oesophageal Doppler-guided fluid administration
Device: Oesophageal Doppler
Non-invasive measurement of doppler-derived cardiovascular variables (CO, aortic flow rate). Used safely over 800, 000 times
Other Name: CardioQ Deltex Oesophageal Doppler

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consecutive patients undergoing open/ laparoscopic colonic resection at Manukau surgical Centre (MSC)or North Shore Hospital, Auckland.

Exclusion Criteria:

  • severe oesophageal disease
  • recent oesophageal or upper airway surgery
  • moderate or severe aortic valve disease as proven by echocardiogram
  • documented bleeding diathesis
  • preoperative steroid use
  • cognitive impairment
  • ASA>3
  • patient choice.
  • rectal tumour (defined as less an 15cm from anal verge on preop investigations)
  • creation of stoma
  • difficulty in obtaining reliable measurements from ODM
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00911391

Locations
New Zealand
North Shore Hospital
Auckland, New Zealand
Manukau Surgery Centre-Middlemore Hospital
Auckland, New Zealand, 2240
Sponsors and Collaborators
University of Auckland, New Zealand
Counties Manukau District Health Board
Waitemata District Health Board
Investigators
Principal Investigator: Andrew G Hill, MBChB MD FRACS South Auckland Clinical School, University of Auckland
  More Information

Additional Information:
No publications provided by University of Auckland, New Zealand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SACS, Associate Professor Andrew G Hill, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT00911391     History of Changes
Other Study ID Numbers: GDFT RCT
Study First Received: May 28, 2009
Last Updated: November 25, 2011
Health Authority: New Zealand: Health and Disability Ethics Committees
New Zealand: Institutional Review Board

Keywords provided by University of Auckland, New Zealand:
Doppler
Colectomy
ERAS
Fluid
Perioperative Care

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014