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

NCT01416077 | Completed Phase 4 DMC

• 1 other identifier: USANOP001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Cancer

Keywords

fluid; goal-directed; FloTrac; pulse contour analysis; postoperative complications; anesthesia; esophagus

Outcome Measures

Primary Outcomes (1)

• Incidence of complications 5 and 30 days postoperatively

  5 and 30 days postoperatively

Secondary Outcomes (2)

• length of stay ICU and total hospital

  30 days

• return of bowel function

  30 days

Study Arms (2)

standard treatment

NO INTERVENTION

Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.

goal-directed fluid treatment

ACTIVE COMPARATOR

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

Other: fluid optimisation

Interventions

fluid optimisation OTHER

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 (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. 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.

goal-directed fluid treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital Linkoeping

Linköping, 58246, Sweden

Location

Related 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.

  PMID: 30431499 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lena Nilsson, MD PhD

  University Hospital, Linkoeping

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD pHd

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

SE (1)