Fluid Management in Patients Undergoing Cardiac Surgery

NCT02895659 | Completed Phase 4

• 1 other identifier: 20160804.1.3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

fluid management; critical illness; hemodynamics; buffered infusates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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))

Study Arms (2)

Ringer lactate

ACTIVE COMPARATOR

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)

Ringer acetate

ACTIVE COMPARATOR

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)

Interventions

perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) PROCEDURE

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

Ringer acetate; Ringer lactate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective single heart valve replacement
• Elective double valve replacement
• Elective single or double valve replacement and coronary artery bypass grafting

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31060591 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Carmen A Pfortmueller, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 12, 2016
• Study Start: December 1, 2016
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)