Hemacetat: Fluid Management in Patients Undergoing Cardiac Surgery

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Completed

CT.gov ID

NCT02895659

Collaborator

(none)

150

Enrollment

Location

Arms

10.6

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Oct 19, 2017

Actual Study Completion Date :

Oct 19, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ringer lactate 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) Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Active Comparator: Ringer acetate 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.

Arm

Intervention/Treatment

Active Comparator: Ringer lactate

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)

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

Active Comparator: Ringer acetate

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.

Outcome Measures

Primary Outcome Measures

Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]

Secondary Outcome Measures

Time on inopressors [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]
Cumulative dose of inodilators [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]
Time on inodilators [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]
Cumulative dose of vasodilatators [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]
Time on vasodilatators [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]
Total amount of fluid [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]
Changes in acid-base status [Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)