Clinical trial NCT02895659: Fluid Management in Patients Undergoing Cardiac Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Keywords: fluid management
critical illness
hemodynamics
buffered infusates
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary outcomes:
measure: Time on inopressors
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
measure: Cumulative dose of inodilators
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
measure: Time on inodilators
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
measure: Cumulative dose of vasodilatators
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
measure: Time on vasodilatators
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
measure: Total amount of fluid
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
measure: Changes in acid-base status
timeFrame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Study officials:
affiliation: Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
name: Carmen A Pfortmueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfortmueller CA, Faeh L, Muller M, Eberle B, Jenni H, Zante B, Prazak J, Englberger L, Takala J, Jakob SM. Fluid management in patients undergoing cardiac surgery: effects of an acetate- versus lactate-buffered balanced infusion solution on hemodynamic stability (HEMACETAT). Crit Care. 2019 May 6;23(1):159. doi: 10.1186/s13054-019-2423-8.