Perioperative fluid management in patients undergoing major surgery and its effect on blood pressure

Perioperative fluid management in patients receiving major abdominal surgery – Effects of normal saline versus an acetate buffered balanced infusion solution on the necessity of catecholamines for cardiocirculatory support

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004867-19-AT

Enrollment

Unknown

Registered

2015-01-20

Start date

2015-02-24

Completion date

Unknown

Last updated

2016-05-30

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

Conditions

hemodynamic stability of patients undergoing major surgery

Interventions

Trade Name: Elomel isoton ?Fresenius Kabi Austria GmbH Product Name: Elomel isoton Pharmaceutical Form: Infusion INN or Proposed INN: - CAS Number: 8026-10-6 Current Sponsor code: 1 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours will be included in the study. Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy. Major general surgery includes complex visceral resection (surgery involving the liver, esophagus, pancreas or multiple organs), partial or total colectomy, stomach surgery, small bowel resection, open gall-bladder resection, splenektomie, adrenalektomie and regional lymphnode dissection. Major urological or gynecological surgery includes renal transplant, nephrectomie, visceral resection (ureterectomy, bladder resection, retroperitoneal tumor resection, exenteration), cytoreductive surgery (tumor debulking), radical hysterectomy, radical prostatectomy and open hysterectomy. 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 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients younger than 18 years of age - Patients unable to give informed consent - Pregnancy or breastfeeding - Patients transferred form the intensive care unit to the operating theater - Patients with an already established catecholamine therapy - Emergency operation - Chronic inflammatory diseases (chronic inflammatory rheumatoid diseases, chronic inflammatory renal diseases, chronic inflammatory infectious diseases, chronic inflammatory bowel diseases, chronic liver disease with signs of liver insufficiency) - Severe cardiovascular disease (heart disease with an ejection fraction below 30%, instable coronary syndroms, severe valvular disease) - Any signs of infection or sepsis - Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection) - Patients with additional epidural anesthesia are excluded from the study if epidural anesthesia is planned to be used for analgesia intraoperatively. - Patients not able to understand the consenting information without help of a translator are excluded from the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: In this study we want to clarify whether a balanced type fluid solution for perioperative fluid management of patients receiving major abdominal surgery is associated with a lower incidence of need for catecholamines for hemodynamic stability than use of isotonic saline.;Secondary Objective: balanced infusion solutions results in a lower volume of fluid needed to achieve cardiovascular stability, lower total dosage of catecholamines as well as lower frequency of unexpected intensive care unit transfers (ICU) than with administration of isotonic saline. Additionally, we will evaluate whether use of an acetate buffered balanced infusion solutions results in lower incidence rates of metabolic acidosis and electrolyte disorders than use of isotonic saline.;Primary end point(s): necessity of catecholamines for cardiocirculatory support;Timepoint(s) of evaluation of this end point: necessity of catecholamines for cardiocirculatory support yes or no	—

Measure

Time frame

Main Objective: In this study we want to clarify whether a balanced type fluid solution for perioperative fluid management of patients receiving major abdominal surgery is associated with a lower incidence of need for catecholamines for hemodynamic stability than use of isotonic saline.;Secondary Objective: balanced infusion solutions results in a lower volume of fluid needed to achieve cardiovascular stability, lower total dosage of catecholamines as well as lower frequency of unexpected intensive care unit transfers (ICU) than with administration of isotonic saline. Additionally, we will evaluate whether use of an acetate buffered balanced infusion solutions results in lower incidence rates of metabolic acidosis and electrolyte disorders than use of isotonic saline.;Primary end point(s): necessity of catecholamines for cardiocirculatory support;Timepoint(s) of evaluation of this end point: necessity of catecholamines for cardiocirculatory support yes or no

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Secondary

Measure	Time frame
Secondary end point(s): - time of vasopressor start - dose of vasopressor start - type of vasopressor used - maximal dose of vasopressor - frequency of vasopressor use - cumulative intraoperative vasopressor dose per kg of body weight - cumulative intraoperative crystalloids - total amount of fluid given at the time of the start of the catecholamine therapy;Timepoint(s) of evaluation of this end point: end of operation	—

Measure

Time frame

Secondary end point(s): - time of vasopressor start - dose of vasopressor start - type of vasopressor used - maximal dose of vasopressor - frequency of vasopressor use - cumulative intraoperative vasopressor dose per kg of body weight - cumulative intraoperative crystalloids - total amount of fluid given at the time of the start of the catecholamine therapy;Timepoint(s) of evaluation of this end point: end of operation

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Countries

Austria

Contacts

Public ContactHead of Department

Clinic for General Anesthesiology, Intensive Care and Pain Management

anesthesie@meduniwien.ac.at0041140100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 8, 2026