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Randomised Trial of Doppler-Optimised Fluid Balance in Elective Colectomy

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ClinicalTrials.gov Identifier: NCT00911391
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : November 29, 2011
Sponsor:
Collaborators:
Counties Manukau Health
Waitemata District Health Board
Information provided by (Responsible Party):
SACS, University of Auckland, New Zealand

Brief Summary:
Perioperative fluid management has been historically dictated by outdated, contradictory concepts.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 or disease Intervention/treatment Phase
Colorectal Cancer Colectomy Surgery Perioperative Care Device: Oesophageal Doppler Procedure: Intraoperative fluid restriction Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Post-operative functional recovery [ Time Frame: 7 day ]

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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00911391


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

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
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by SACS, 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