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)

April 28, 2016 updated by: Pfortmueller Carmen Andrea, Medical University of Vienna

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of General Anesthesiology, Intensive Care and Pain Management, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NaCl 0.9% BBraun (normale saline)
154mmol/l sodium, 154mmol/l chloride
Drug: Normal Saline
Drug: vasopressor
Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor
Other Names:
  • phenylephrine, norepinephrine
Drug: fluid bolus
Device: oesophagus doppler (CardioQ)
Device: arterial cannulation
Device: intravenous peripheral line insertion (17 gauge)
for fluid bolus administration
Active Comparator: Elo-Mel Isoton (balanced acetat-based infusate)
sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l
Drug: vasopressor
Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor
Other Names:
  • phenylephrine, norepinephrine
Drug: fluid bolus
Device: oesophagus doppler (CardioQ)
Device: arterial cannulation
Device: intravenous peripheral line insertion (17 gauge)
for fluid bolus administration
Drug: Elo-Mel Isoton (balanced acetat-based infusate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
catecholamine use to maintain target mean arterial pressure
Time Frame: hours of anesthesia (max 10 hours)
hours of anesthesia (max 10 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
difference in dose of catecholamines to maintain cardiovascular stability
Time Frame: hours of anesthesia (max 10 hours)
hours of anesthesia (max 10 hours)
difference in volume to maintain cardiovascular stability
Time Frame: hours of anesthesia (max 10 hours)
hours of anesthesia (max 10 hours)
unplanned ICU transfers
Time Frame: hours of anesthesia (max 10 hours)
hours of anesthesia (max 10 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Director: Klaus Markstaller, MD, Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v1.104112014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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