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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01416077
Other study ID # USANOP001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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