Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01416077
First received: August 11, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Esophageal Cancer
Other: fluid optimisation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Incidence of complications 5 and 30 days postoperatively [ Time Frame: 5 and 30 days postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • length of stay ICU and total hospital [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • return of bowel function [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard treatment
Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.
Active Comparator: goal-directed fluid treatment
Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised
Other: fluid optimisation

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

  1. Crystalloid infusion (2,5 ml/kg/t) throughout surgery
  2. 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.
  3. If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI > 2,5.
  4. If despite CI > 2,5 Mean Arterial Pressure <65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416077

Locations
Sweden
University Hospital Linkoeping Recruiting
Linkoeping, Sweden, 58246
Contact: Lena Nilsson    +46-10-1031838    lena.nilsson@ds.se   
Principal Investigator: Lena Nilsson, MD PhD         
Sub-Investigator: Hans Bahlmann, MD         
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Study Chair: Lena Nilsson, MD PhD University Hospital, Linkoeping
  More Information

No publications provided

Responsible Party: Lena Nilsson, MD pHd, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01416077     History of Changes
Other Study ID Numbers: USANOP001
Study First Received: August 11, 2011
Last Updated: October 23, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
fluid
goal-directed
FloTrac
pulse contour analysis
postoperative complications
anesthesia
esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Postoperative Complications
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014