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

Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01416077

Enrollment

Registered

2011-08-12

Start date

2011-10-31

Completion date

2015-10-31

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

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

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).

Interventions

OTHERfluid 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 (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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of complications 5 and 30 days postoperatively	5 and 30 days postoperatively

Secondary

Measure	Time frame
length of stay ICU and total hospital	30 days
return of bowel function	30 days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026