Critical IllnessPhase 4KATECHOLNCT02414555
Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support
A Phase 4 study testing vasopressor, fluid bolus and oesophagus doppler (CardioQ) in people with Critical Illness, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Background Intraoperative hypotension is a common problem that significantly contributes to perioperative mortality and morbidity. At the moment the "gold standard" for perioperative fluid management is the so called "goal-directed therapy" that features fluid resuscitation followed if necessary catecholamines if… 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?
- vasopressor, fluid bolus and oesophagus doppler (CardioQ)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2015to Mar 2016
- 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
- All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours will be included in the study.
- (Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy)
Who cannot join
- Patients younger than 18 years of age
- Patients unable to give informed consent
- Pregnancy or breastfeeding
- Patients transferred form the intensive care unit to the operating theater
- Patients with an already established catecholamine therapy
- Emergency operation
Show all 12Show fewer
- Chronic inflammatory diseases (chronic inflammatory rheumatoid diseases, chronic inflammatory renal diseases, chronic inflammatory infectious diseases, chronic inflammatory bowel diseases, chronic liver disease with signs of liver insufficiency)
- Severe cardiovascular disease (heart disease with an ejection fraction below 30%, instable coronary syndromes, severe valvular disease)
- Any signs of infection or sepsis
- Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection)
- Renal insufficiency with a glomerular filtration rate below 30ml/min
- Patients with additional epidural anesthesia are excluded from the study if epidural anesthesia is planned to be used for analgesia intraoperatively
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of General Anesthesiology, Intensive Care and Pain Management, Medical University of Vienna
Vienna, 1090
About this study
Official title: Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support, a Randomized Controlled Double-blind Trial
Background Intraoperative hypotension is a common problem that significantly contributes to perioperative mortality and morbidity. At the moment the "gold standard" for perioperative fluid management is the so called "goal-directed therapy" that features fluid resuscitation followed if necessary catecholamines if needed for perioperative cardiocirculatory support.
Worldwide the so called "physiological" sodium chlorid (0.9% NaCl) solution is the most often used infusate for perioperative fluid management. Despite its widespread use physiological saline has its major disadvantages such as the increased incidence of metabolic acidosis. Nevertheless catecholamines have their significant side effects as well (eg diminished renal perfusion, increased cardiovascular morbidity) and they therefore should be used with caution.
Read more
In a prior study by group members on patients undergoing renal transplantation receiving either physiological saline or an acetate-buffered infusate showed a 50% decrease in catecholamine necessity in the acetate-buffered infusate group. The investigators therefore would like to evaluate the effects of the perioperative fluid choice on the necessity of catecholamine use.
Aim
- Evaluation of the perioperative fluid choice on the necessity of catecholamines for cardiocirculatory support.
- Description of the relationship between perioperative fluid choice and minimal blood pressure as well as the time to catecholamine use and their dosage.
Methods The investigators plan a prospective randomized-controlled trial of all patients undergoing major abdominal surgery at the Vienna General Hospital and Medical University of Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based treatment scheme.
- Conditions
- Critical Illness
- Being tested
- vasopressor, fluid bolus, oesophagus doppler (CardioQ), Normal Saline, arterial cannulation
- Keywords
- Fluid Management
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasopressorDrug
Also called phenylephrine, norepinephrine
Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor
fluid bolusDrug
oesophagus doppler (CardioQ)Device
Normal SalineDrug
arterial cannulationDevice
intravenous peripheral line insertion (17 gauge)Device
for fluid bolus administration
Elo-Mel Isoton (balanced acetat-based infusate)Drug
| Study group | Role | What they receive |
|---|---|---|
| NaCl 0.9% BBraun (normale saline) | Active comparator | 154mmol/l sodium, 154mmol/l chloride Receives: Drug: vasopressor; Drug: fluid bolus; Device: oesophagus doppler (CardioQ); Drug: Normal Saline; Device: arterial cannulation; Device: intravenous peripheral line insertion (17 gauge) |
| Elo-Mel Isoton (balanced acetat-based infusate) | Active comparator | sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l Receives: Drug: vasopressor; Drug: fluid bolus; Device: oesophagus doppler (CardioQ); Device: arterial cannulation; Device: intravenous peripheral line insertion (17 gauge); Drug: Elo-Mel Isoton (balanced acetat-based infusate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
catecholamine use to maintain target mean arterial pressure
Measured: hours of anesthesia (max 10 hours)
Secondary outcomes (3)
difference in dose of catecholamines to maintain cardiovascular stability
Measured: hours of anesthesia (max 10 hours)
difference in volume to maintain cardiovascular stability
Measured: hours of anesthesia (max 10 hours)
unplanned ICU transfers
Measured: hours of anesthesia (max 10 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Patient Safety
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pfortmueller Carmen Andrea, Medical University of Vienna
- Investigators
- Klaus Markstaller, MD, Study director, Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414555
- Sponsor's protocol ID
- v1.104112014
- Acronym
- KATECHOL
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2015
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pfortmueller CA, Funk GC, Reiterer C, Schrott A, Zotti O, Kabon B, Fleischmann E, Lindner G. Normal saline versus a balanced crystalloid for goal-directed perioperative fluid therapy in major abdominal surgery: a double-blind randomised controlled study. Br J Anaesth. 2018 Feb;120(2):274-283. doi: 10.1016/j.bja.2017.11.088. Epub 2017 Dec 2.
PubMed 29406176
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support, a Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT02414555
- Acronym / sponsor ID
- KATECHOL / v1.104112014
- Conditions
- Critical Illness
- Keywords
- Fluid Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient Safety
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Apr 2015 (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 Intraoperative hypotension is a common problem that significantly contributes to perioperative mortality and morbidity. At the moment the "gold standard" for perioperative fluid management is the so called "goal-directed therapy" that features fluid resuscitation followed if necessary catecholamines if needed for perioperative cardiocirculatory support.
Worldwide the so called "physiological" sodium chlorid (0.9% NaCl) solution is the most often used infusate for perioperative fluid management. Despite its widespread use physiological saline has its major disadvantages such as the increased incidence of metabolic acidosis. Nevertheless catecholamines have their significant side effects as well (eg diminished renal perfusion, increased cardiovascular morbidity) and they therefore should be used with caution.
In a prior study by group members on patients undergoing renal transplantation receiving either physiological saline or an acetate-buffered infusate showed a 50% decrease in catecholamine necessity in the acetate-buffered infusate group. The investigators therefore would like to evaluate the effects of the perioperative fluid choice on the necessity of catecholamine use.
Aim
- Evaluation of the perioperative fluid choice on the necessity of catecholamines for cardiocirculatory support.
- Description of the relationship between perioperative fluid choice and minimal blood pressure as well as the time to catecholamine use and their dosage.
Methods The investigators plan a prospective randomized-controlled trial of all patients undergoing major abdominal surgery at the Vienna General Hospital and Medical University of Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based treatment scheme.
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 |
|---|---|---|
| NaCl 0.9% BBraun (normale saline) | Active comparator | Drug: vasopressor, Drug: fluid bolus, Device: oesophagus doppler (CardioQ), Drug: Normal Saline, Device: arterial cannulation, Device: intravenous peripheral line insertion (17 gauge)154mmol/l sodium, 154mmol/l chloride |
| Elo-Mel Isoton (balanced acetat-based infusate) | Active comparator | Drug: vasopressor, Drug: fluid bolus, Device: oesophagus doppler (CardioQ), Device: arterial cannulation, Device: intravenous peripheral line insertion (17 gauge), Drug: Elo-Mel Isoton (balanced acetat-based infusate)sodium 140mmol/l, potassium 5.0mmol/l, calcium 2.5mmol/l, magnesium 1.5mmol/l, chlorid 108mmol/l, acetate 45mmol/l |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours will be included in the study.
- (Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy)
Key exclusion criteria (12 listed)
- Patients younger than 18 years of age
- Patients unable to give informed consent
- Pregnancy or breastfeeding
- Patients transferred form the intensive care unit to the operating theater
- Patients with an already established catecholamine therapy
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 |
|---|---|---|
| vasopressorAlso: phenylephrine, norepinephrinePatients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor | Drug | Elo-Mel Isoton (balanced acetat-based infusate), NaCl 0.9% BBraun (normale saline) |
| fluid bolus | Drug | Elo-Mel Isoton (balanced acetat-based infusate), NaCl 0.9% BBraun (normale saline) |
| oesophagus doppler (CardioQ) | Device | Elo-Mel Isoton (balanced acetat-based infusate), NaCl 0.9% BBraun (normale saline) |
| Normal Saline | Drug | NaCl 0.9% BBraun (normale saline) |
| arterial cannulation | Device | Elo-Mel Isoton (balanced acetat-based infusate), NaCl 0.9% BBraun (normale saline) |
| intravenous peripheral line insertion (17 gauge)for fluid bolus administration | Device | Elo-Mel Isoton (balanced acetat-based infusate), NaCl 0.9% BBraun (normale saline) |
| Elo-Mel Isoton (balanced acetat-based infusate) | Drug | Elo-Mel Isoton (balanced acetat-based infusate) |
Primary outcome
catecholamine use to maintain target mean arterial pressure
Time frame: hours of anesthesia (max 10 hours)
3 secondary outcomes
difference in dose of catecholamines to maintain cardiovascular stability
Time frame: hours of anesthesia (max 10 hours)
difference in volume to maintain cardiovascular stability
Time frame: hours of anesthesia (max 10 hours)
unplanned ICU transfers
Time frame: hours of anesthesia (max 10 hours)
Results and safety
The study was stopped early (reason given: Patient Safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Derived from this study: PubMed 29406176Pfortmueller CA, Funk GC, Reiterer C, Schrott A, Zotti O, Kabon B, Fleischmann E, Lindner G. Normal saline versus a balanced crystalloid for goal-directed perioperative fluid therapy in major abdominal surgery: a double-blind randomised controlled study. Br J Anaesth. 2018 Feb;120(2):274-283. doi: 10.1016/j.bja.2017.11.088. Epub 2017 Dec 2.
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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.
Klaus Markstaller, MD study director
Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria
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 vasopressor, fluid bolus and oesophagus doppler (CardioQ) in people with Critical Illness, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 May 2016. 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 Austria. 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 was stopped early (reason given: Patient Safety). Results are not available in the source record.
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?
catecholamine use to maintain target mean arterial pressure (time frame: hours of anesthesia (max 10 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 NCT02414555, 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 2 May 2016.