Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
fluid optimisation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring fluid, goal-directed, FloTrac, pulse contour analysis, postoperative complications, anesthesia, esophagus
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent
Exclusion Criteria:
- ASA 4 or 5
- Atrial Fibrillation
- Significant Aortic or Mitral Valve Insufficiency
- Preoperative planned extensive monitoring beyond CVP, arterial blood pressure, diuresis, ECG and other standard monitors
Sites / Locations
- University Hospital Linkoeping
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
standard treatment
goal-directed fluid treatment
Arm Description
Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.
Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised
Outcomes
Primary Outcome Measures
Incidence of complications 5 and 30 days postoperatively
Secondary Outcome Measures
length of stay ICU and total hospital
return of bowel function
Full Information
NCT ID
NCT01416077
First Posted
August 11, 2011
Last Updated
December 1, 2015
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT01416077
Brief Title
Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection
Official Title
Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
fluid, goal-directed, FloTrac, pulse contour analysis, postoperative complications, anesthesia, esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard treatment
Arm Type
No Intervention
Arm Description
Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.
Arm Title
goal-directed fluid treatment
Arm Type
Active Comparator
Arm Description
Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised
Intervention Type
Other
Intervention Name(s)
fluid optimisation
Intervention Description
Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised
Crystalloid infusion (2,5 ml/kg/t) throughout surgery
3 ml/kg Volulyte (artifical colloid) is infused during 5 minutes and SV is measured directly before and 5 minutes after. If SV increases more than 10% the dose is repeated until no increase > 10% is observed. A new dose is given if SV decreases more than 10% from the last value.
If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI > 2,5.
If despite CI > 2,5 Mean Arterial Pressure <65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65.
Primary Outcome Measure Information:
Title
Incidence of complications 5 and 30 days postoperatively
Time Frame
5 and 30 days postoperatively
Secondary Outcome Measure Information:
Title
length of stay ICU and total hospital
Time Frame
30 days
Title
return of bowel function
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent
Exclusion Criteria:
ASA 4 or 5
Atrial Fibrillation
Significant Aortic or Mitral Valve Insufficiency
Preoperative planned extensive monitoring beyond CVP, arterial blood pressure, diuresis, ECG and other standard monitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Nilsson, MD PhD
Organizational Affiliation
University Hospital, Linkoeping
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Linkoeping
City
Linkoeping
ZIP/Postal Code
58246
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
30431499
Citation
Bahlmann H, Halldestam I, Nilsson L. Goal-directed therapy during transthoracic oesophageal resection does not improve outcome: Randomised controlled trial. Eur J Anaesthesiol. 2019 Feb;36(2):153-161. doi: 10.1097/EJA.0000000000000908.
Results Reference
derived
Learn more about this trial
Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection
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