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Completed

NCT Number: NCT02895659

Fluid Management in Patients Undergoing Cardiac Surgery

Background: Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intra- and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. Despite continuing evaluation no superiority of one particular type of fluid has been reached so far. To the best of the investigators' knowledge no study in humans has ever assessed whether the type of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac performance

Primary Aim: In this study the investigators want to clarify whether a balanced type acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective single heart valve replacement
  • Elective double valve replacement
  • Elective single or double valve replacement and coronary artery bypass grafting

Exclusion criteria

  • Patients unable to give informed consent
  • Patients younger than 18 years of age or older than 80 years
  • Pregnancy or breastfeeding
  • Ejection fraction (EF) of less than 30% preoperatively
  • Preexisting renal insufficiency with a glomerular filtration rate below 30ml/min
  • Patients transferred form the intensive care unit to the operating theater
  • Emergency operation
  • Reoperation
  • Patients planned for fast-track surgery
  • Patients planned for minimal extracorporal circuits
  • Preexisting anemia requiring immediate perioperative blood transfusion
  • Chronic inflammatory diseases
  • Any signs of infection or sepsis
  • Limitation of full therapy (e.g. Jehowa's witnesses)

Treatment and study plan

perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)

Procedure

Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Primary outcomes

  1. Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

Secondary outcomes

  1. Time on inopressors

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

  2. Cumulative dose of inodilators

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

  3. Time on inodilators

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

  4. Cumulative dose of vasodilatators

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

  5. Time on vasodilatators

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

  6. Total amount of fluid

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

  7. Changes in acid-base status

    Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Fluid Management in Patients Undergoing Cardiac Surgery - Effects of an Acetate Versus Lactate Buffered Balanced Infusion Solution on Hemodynamic Stability, a Randomized Controlled Double-blind Trial

Acronym: Hemacetat

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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