Critical IllnessPhase 4HemacetatNCT02895659
Fluid Management in Patients Undergoing Cardiac Surgery
A Phase 4 study testing perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) in people with Critical Illness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2016to 19 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective single heart valve replacement
- Elective double valve replacement
- Elective single or double valve replacement and coronary artery bypass grafting
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
Bern, 3010
About this study
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
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
- Being tested
- perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
- Keywords
- fluid management, critical illness, hemodynamics, buffered infusates
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)Procedure or surgery
Perioperative hemodynamic management will be performed according to a specified treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Secondary outcomes (7)
Time on inopressors
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of inodilators
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on inodilators
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of vasodilatators
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on vasodilatators
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Total amount of fluid
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Changes in acid-base status
Measured: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start1 Dec 2016
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen A Pfortmueller, MD, Principal investigator, Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895659
- Sponsor's protocol ID
- 20160804.1.3
- Acronym
- Hemacetat
- Status last verified
- Nov 2017
- First submitted
- 30 Aug 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31060591
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02895659
- Acronym / sponsor ID
- Hemacetat / 20160804.1.3
- Conditions
- Critical Illness
- Keywords
- fluid management, critical illness, hemodynamics, buffered infusates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer lactate | Active comparator | Procedure: 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. |
| Ringer acetate | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective single heart valve replacement
- Elective double valve replacement
- Elective single or double valve replacement and coronary artery bypass grafting
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)Perioperative hemodynamic management will be performed according to a specified treatment protocol. | Procedure or surgery | Ringer acetate, Ringer lactate |
Primary outcome
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))
7 secondary outcomes
Time on inopressors
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of inodilators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on inodilators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of vasodilatators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on vasodilatators
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Total amount of fluid
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Changes in acid-base status
Time frame: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 31060591Pfortmueller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen A Pfortmueller, MD principal investigator
Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect) in people with Critical Illness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.