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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416077
• Other study ID #: USANOP001
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2023
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Postoperative Complications

Intervention

Other:
• fluid optimisation
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 (synthetic 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.

Locations

Country	Name	City	State
Sweden	University Hospital Linkoeping	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications 5 and 30 days postoperatively		5 and 30 days postoperatively
Secondary	length of stay ICU and total hospital		30 days
Secondary	return of bowel function		30 days