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

NCT02414555 | Terminated Phase 4 DMC

• 1 other identifier: v1.104112014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Fluid Management

Outcome Measures

Primary Outcomes (1)

• catecholamine use to maintain target mean arterial pressure

  hours of anesthesia (max 10 hours)

Secondary Outcomes (3)

• difference in dose of catecholamines to maintain cardiovascular stability

  hours of anesthesia (max 10 hours)

• difference in volume to maintain cardiovascular stability

  hours of anesthesia (max 10 hours)

• unplanned ICU transfers

  hours of anesthesia (max 10 hours)

Study Arms (2)

NaCl 0.9% BBraun (normale saline)

ACTIVE COMPARATOR

154mmol/l sodium, 154mmol/l chloride

Drug: vasopressor; Drug: fluid bolus; Device: oesophagus doppler (CardioQ); Drug: Normal Saline; Device: arterial cannulation; Device: intravenous peripheral line insertion (17 gauge)

Elo-Mel Isoton (balanced acetat-based infusate)

ACTIVE COMPARATOR

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

Drug: vasopressor; Drug: fluid bolus; Device: oesophagus doppler (CardioQ); Device: arterial cannulation; Device: intravenous peripheral line insertion (17 gauge); Drug: Elo-Mel Isoton (balanced acetat-based infusate)

Interventions

vasopressor DRUG

Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor

Also known as: phenylephrine, norepinephrine

Elo-Mel Isoton (balanced acetat-based infusate); NaCl 0.9% BBraun (normale saline)

fluid bolus DRUG

Elo-Mel Isoton (balanced acetat-based infusate); NaCl 0.9% BBraun (normale saline)

oesophagus doppler (CardioQ) DEVICE

Elo-Mel Isoton (balanced acetat-based infusate); NaCl 0.9% BBraun (normale saline)

Normal Saline DRUG

NaCl 0.9% BBraun (normale saline)

arterial cannulation DEVICE

Elo-Mel Isoton (balanced acetat-based infusate); NaCl 0.9% BBraun (normale saline)

intravenous peripheral line insertion (17 gauge) DEVICE

for fluid bolus administration

Elo-Mel Isoton (balanced acetat-based infusate); NaCl 0.9% BBraun (normale saline)

Elo-Mel Isoton (balanced acetat-based infusate) DRUG

Elo-Mel Isoton (balanced acetat-based infusate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 29406176 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Vasoconstrictor Agents; Phenylephrine; Norepinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Klaus Markstaller, MD

  Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Intensive Care and Pain Management

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 10, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

AU (1)