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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 (KATECHOL)

Primary Purpose

Critical Illness

Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
vasopressor
fluid bolus
oesophagus doppler (CardioQ)
Normal Saline
arterial cannulation
intravenous peripheral line insertion (17 gauge)
Elo-Mel Isoton (balanced acetat-based infusate)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Fluid Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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 syndromes, severe valvular disease)
  • Any signs of infection or sepsis
  • Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection)
  • Renal insufficiency with a glomerular filtration rate below 30ml/min
  • Patients with additional epidural anesthesia are excluded from the study if epidural anesthesia is planned to be used for analgesia intraoperatively

Sites / Locations

  • Department of General Anesthesiology, Intensive Care and Pain Management, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NaCl 0.9% BBraun (normale saline)

Elo-Mel Isoton (balanced acetat-based infusate)

Arm Description

154mmol/l sodium, 154mmol/l chloride

sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l

Outcomes

Primary Outcome Measures

catecholamine use to maintain target mean arterial pressure

Secondary Outcome Measures

difference in dose of catecholamines to maintain cardiovascular stability
difference in volume to maintain cardiovascular stability
unplanned ICU transfers

Full Information

First Posted
March 23, 2015
Last Updated
April 28, 2016
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02414555
Brief Title
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
Acronym
KATECHOL
Official Title
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, a Randomized Controlled Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Patient Safety
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background Intraoperative hypotension is a common problem that significantly contributes to perioperative mortality and morbidity. At the moment the "gold standard" for perioperative fluid management is the so called "goal-directed therapy" that features fluid resuscitation followed if necessary catecholamines if needed for perioperative cardiocirculatory support. Worldwide the so called "physiological" sodium chlorid (0.9% NaCl) solution is the most often used infusate for perioperative fluid management. Despite its widespread use physiological saline has its major disadvantages such as the increased incidence of metabolic acidosis. Nevertheless catecholamines have their significant side effects as well (eg diminished renal perfusion, increased cardiovascular morbidity) and they therefore should be used with caution. In a prior study by group members on patients undergoing renal transplantation receiving either physiological saline or an acetate-buffered infusate showed a 50% decrease in catecholamine necessity in the acetate-buffered infusate group. The investigators therefore would like to evaluate the effects of the perioperative fluid choice on the necessity of catecholamine use. Aim Evaluation of the perioperative fluid choice on the necessity of catecholamines for cardiocirculatory support. Description of the relationship between perioperative fluid choice and minimal blood pressure as well as the time to catecholamine use and their dosage. Methods The investigators plan a prospective randomized-controlled trial of all patients undergoing major abdominal surgery at the Vienna General Hospital and Medical University of Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based treatment scheme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Fluid Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NaCl 0.9% BBraun (normale saline)
Arm Type
Active Comparator
Arm Description
154mmol/l sodium, 154mmol/l chloride
Arm Title
Elo-Mel Isoton (balanced acetat-based infusate)
Arm Type
Active Comparator
Arm Description
sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l
Intervention Type
Drug
Intervention Name(s)
vasopressor
Other Intervention Name(s)
phenylephrine, norepinephrine
Intervention Description
Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor
Intervention Type
Drug
Intervention Name(s)
fluid bolus
Intervention Type
Device
Intervention Name(s)
oesophagus doppler (CardioQ)
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Type
Device
Intervention Name(s)
arterial cannulation
Intervention Type
Device
Intervention Name(s)
intravenous peripheral line insertion (17 gauge)
Intervention Description
for fluid bolus administration
Intervention Type
Drug
Intervention Name(s)
Elo-Mel Isoton (balanced acetat-based infusate)
Primary Outcome Measure Information:
Title
catecholamine use to maintain target mean arterial pressure
Time Frame
hours of anesthesia (max 10 hours)
Secondary Outcome Measure Information:
Title
difference in dose of catecholamines to maintain cardiovascular stability
Time Frame
hours of anesthesia (max 10 hours)
Title
difference in volume to maintain cardiovascular stability
Time Frame
hours of anesthesia (max 10 hours)
Title
unplanned ICU transfers
Time Frame
hours of anesthesia (max 10 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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 syndromes, severe valvular disease) Any signs of infection or sepsis Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection) Renal insufficiency with a glomerular filtration rate below 30ml/min Patients with additional epidural anesthesia are excluded from the study if epidural anesthesia is planned to be used for analgesia intraoperatively
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Markstaller, MD
Organizational Affiliation
Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria
Official's Role
Study Director
Facility Information:
Facility Name
Department of General Anesthesiology, Intensive Care and Pain Management, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
29406176
Citation
Pfortmueller CA, Funk GC, Reiterer C, Schrott A, Zotti O, Kabon B, Fleischmann E, Lindner G. Normal saline versus a balanced crystalloid for goal-directed perioperative fluid therapy in major abdominal surgery: a double-blind randomised controlled study. Br J Anaesth. 2018 Feb;120(2):274-283. doi: 10.1016/j.bja.2017.11.088. Epub 2017 Dec 2.
Results Reference
derived

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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

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