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

Phase 4

Completed

• Conditions: Esophageal Cancer
• Interventions: Other: fluid optimisation

• Registration Number: NCT01416077
• Lead Sponsor: University Hospital, Linkoeping

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Start: 2011-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
goal-directed fluid treatment	fluid optimisation	Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

Primary Outcome Measures

Name	Time	Method
Incidence of complications 5 and 30 days postoperatively	5 and 30 days postoperatively

Secondary Outcome Measures

Name	Time	Method
length of stay ICU and total hospital	30 days
return of bowel function	30 days

Trial Locations

Locations (1)

University Hospital Linkoeping; 🇸🇪 Linköping, Sweden