A Phase 4 interventional study of perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) in Critical Illness, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 4, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 150 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Perioperative hemodynamic management will be performed according to a specified treatment protocol.
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))
Time on inopressors
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of inodilators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on inodilators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of vasodilatators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on vasodilatators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Total amount of fluid
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Changes in acid-base status
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Plan to share: No
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Insel Gruppe AG, University Hospital Bern