Fluid Management in Patients Undergoing Cardiac Surgery (Hemacetat)

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 4

Conditions: Critical Illness

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02895659

20160804.1.3

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Ringer lactate

Active Comparator group

Description:

Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Treatment:

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

Ringer acetate

Active Comparator group

Description:

Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Treatment:

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