Fluid Management in Patients Undergoing Cardiac Surgery

Phase 4

Completed

• Conditions: Critical Illness
• Interventions: Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)

• Registration Number: NCT02895659
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-12
• Study Start: 2016-12-01
• Primary Completion: 2017-10-19
• Study Completion: 2017-10-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer acetate	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.
Ringer lactate	perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)	Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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))
Changes in acid-base status	Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on inopressors	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))

Trial Locations

Locations (1)

Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland; 🇨🇭 Bern, Switzerland