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

Phase 1

• Conditions: hemodynamic stability of patients undergoing major surgery; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004867-19-AT
• Lead Sponsor: Clinic for General Anesthesiology, Intensive Care and Pain Management

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-20
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -time of vasopressor start<br>-dose of vasopressor start<br>-type of vasopressor used<br>-maximal dose of vasopressor<br>-frequency of vasopressor use<br>-cumulative intraoperative vasopressor dose per kg of body weight<br>-cumulative intraoperative crystalloids<br>-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