Fluid Management in Patients Undergoing Cardiac Surgery

Critical Illness Clinical Trial

— Hemacetat  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895659
• Other study ID #: 20160804.1.3
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2016
• Last updated: November 2, 2017
• Start date: December 1, 2016
• Est. completion date: October 19, 2017

Study information

• Verified date: November 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 19, 2017
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time on inopressors		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary	Cumulative dose of inodilators		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary	Time on inodilators		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary	Cumulative dose of vasodilatators		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary	Time on vasodilatators		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary	Total amount of fluid		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary	Changes in acid-base status		Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))