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

NCT01416077 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-12-04

No results posted yet for this study

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

Interventions

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 (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.

Sponsors & Collaborators

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Lena Nilsson, MD PhD · University Hospital, Linkoeping

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416077 on ClinicalTrials.gov