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

NCT ID: NCT01416077

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Esophageal Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

goal-directed fluid treatment

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

Group Type ACTIVE_COMPARATOR

fluid optimisation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Lena Nilsson

MD pHd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lena Nilsson, MD PhD

Role: STUDY_CHAIR

University Hospital, Linkoeping

Locations

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University Hospital Linkoeping

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 30431499 (View on PubMed)

Other Identifiers

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USANOP001

Identifier Type: -

Identifier Source: org_study_id