Steering of administration of intravenous fluids and vasoactive drugs towards set goals during surgery for removal of the esofagus because of cancer

Perioperative Goal Directed Fluid Therapy during Esophageal Resection. A prospective randomized controlled open multi-centre trial to study the effect on postoperative complications

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000254-39-SE

Enrollment

Registered

2011-07-18

Start date

2011-10-11

Completion date

Unknown

Last updated

2020-05-25

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

Conditions

Anesthesia for esophageal resection because of malignancy

Interventions

Product Name: dobutamine Pharmaceutical Form: Infusion INN or Proposed INN: DOBUTAMINE HYDROCHLORIDE CAS Number: 52663817 Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for elective esophageal resection because of malignancy without colon interposition Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - ASA-class 4 or higher - Signifikant aortic/mitral insufficiency - Extensive hemodynamic monitoring planned excluding Invasive Arterial Blood Pressure, ElectroCardioGraphy, Central Venous Pressure and diuresis - Contraindikations to artificila kolloids such as allergy, severe kidney/liverdisease or severe hypernatremia

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by "pulse contour analysis" will result in fewer postoperative complications;Secondary Objective: To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by "pulse contour analysis" will result in a shorter length of stay;Primary end point(s): Postoperative complications;Timepoint(s) of evaluation of this end point: 5 and 30 days post primary surgery	—

Measure

Time frame

Main Objective: To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by "pulse contour analysis" will result in fewer postoperative complications;Secondary Objective: To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by "pulse contour analysis" will result in a shorter length of stay;Primary end point(s): Postoperative complications;Timepoint(s) of evaluation of this end point: 5 and 30 days post primary surgery

—

Secondary

Measure	Time frame
Secondary end point(s): length of stay at ICU and total hospital return of bowel function;Timepoint(s) of evaluation of this end point: 30 days post primary surgery	—

Countries

Sweden

Contacts

Public ContactLena Nilsson

Department of Anesthesia and Intensive Care

lena.nilsson@lio.se460101031838

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026