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Fluid Management in Patients Undergoing Cardiac Surgery (Hemacetat)

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring fluid management, critical illness, hemodynamics, buffered infusates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ringer lactate

Ringer acetate

Arm Description

Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Outcomes

Primary Outcome Measures

Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period

Secondary Outcome Measures

Time on inopressors
Cumulative dose of inodilators
Time on inodilators
Cumulative dose of vasodilatators
Time on vasodilatators
Total amount of fluid
Changes in acid-base status

Full Information

First Posted
August 30, 2016
Last Updated
November 2, 2017
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02895659
Brief Title
Fluid Management in Patients Undergoing Cardiac Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 19, 2017 (Actual)
Study Completion Date
October 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
fluid management, critical illness, hemodynamics, buffered infusates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ringer lactate
Arm Type
Active Comparator
Arm Description
Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Arm Title
Ringer acetate
Arm Type
Active Comparator
Arm Description
Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Intervention Type
Procedure
Intervention Name(s)
perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Intervention Description
Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Primary Outcome Measure Information:
Title
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))
Secondary Outcome Measure Information:
Title
Time on inopressors
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Title
Cumulative dose of inodilators
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Title
Time on inodilators
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Title
Cumulative dose of vasodilatators
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Title
Time on vasodilatators
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Title
Total amount of fluid
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Title
Changes in acid-base status
Time Frame
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen A Pfortmueller, MD
Organizational Affiliation
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31060591
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.
Results Reference
derived

Learn more about this trial

Fluid Management in Patients Undergoing Cardiac Surgery

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