Hemodynamic InstabilityNCT03576261
Heart Failure and Hemodynamic Stability During Anesthesia Induction
A study testing Preoperative colloid fluid bolus (Gelofusine) and Preoperative transthoracic echocardiography in people with Hemodynamic Instability and Anesthesia; Adverse Effect, run by Umeå University at 1 site in Sweden.
Trial summary
The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure
- What is being tested?
- Preoperative colloid fluid bolus (Gelofusine) and Preoperative transthoracic echocardiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2018to 2 Dec 2021
- Phase
- Interventional
- 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
- age over 18 years
- body mass index ≤ 35 kg/m2
- electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery
Who cannot join
- instable angina pectoris
- severe bronchial asthma
- severe COPD
- dementia
- severe heart valve disease
- severe renal failure
- body mass index > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction
The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.
Read the detailed description
40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction.
Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.
- Conditions
- Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure, Diastolic Dysfunction, Venous; Return (Anomaly)
- Being tested
- Preoperative colloid fluid bolus (Gelofusine), Preoperative transthoracic echocardiography
- Keywords
- hemodynamics, venous return, heart failure, anesthesia
- Medical subject headings
- Heart Failure, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative colloid fluid bolus (Gelofusine)Other
Preoperative colloid fluid bolus
Preoperative transthoracic echocardiographyDiagnostic test
Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative echo + fluids | Experimental | 20 individuals investigated by preoperative transthoracic echocardiography. Preoperative colloid fluid bolus (Gelofusine, Fresenius Kabi AB, Sweden) 6 ml/kg lean body weight, is infused intravenously immediately before anesthesia induction. Receives: Other: Preoperative colloid fluid bolus (Gelofusine); Diagnostic Test: Preoperative transthoracic echocardiography |
| Preoperative echo, control | Active comparator | 20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction. Receives: Diagnostic Test: Preoperative transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of blood pressure drops
Blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction .
Measured: 20 minutes post anesthesia induction
Incidence of severe blood pressure drops
Blood pressure drop below mean arterial pressure at 55 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction.
Measured: 20 minutes post anesthesia induction
Secondary outcomes (3)
Venous return and hemodynamic stability
Level of venous return impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Measured: 20 minutes post anesthesia induction
Systolic heart failure and hemodynamic stability
Systolic heart failure impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Measured: 20 minutes post anesthesia induction
Diastolic dysfunction and hemodynamic stability
Diastolic dysfunction impact on blood pressure drops during anesthesia below mean arterial pressure at 65 mmHg
Measured: 20 minutes post anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 Aug 2018
- Primary completion1 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomi Myrberg, Umeå University
- Investigators
- Tomi Myrberg, MD PhD, Principal investigator, Umea Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576261
- Sponsor's protocol ID
- 2016/361-31 III
- Status last verified
- Dec 2021
- First submitted
- 4 Jun 2018
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Heart Failure Has Impact on Hemodynamic Stability During Anesthesia Induction
- ClinicalTrials.gov ID
- NCT03576261
- Acronym / sponsor ID
- 2016/361-31 III
- Conditions
- Hemodynamic Instability, Anesthesia; Adverse Effect, Heart Failure, Diastolic Dysfunction, Venous; Return (Anomaly)
- Keywords
- hemodynamics, venous return, heart failure, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 3 Jul 2018 (actual)
- 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.
The study aim is to investigate whether preoperative heart failure has impact on hemodynamic stability during anesthesia induction by target controlled infusion of anesthesia (TCI) in non-cardiac, non-morbidly obese surgery.
Detailed description
40 individuals are enrolled to the study after signed informed consent at the day of surgery. The study participants are randomized (non-blinded) to preoperative fluid therapy (preoperative colloid fluid bolus at 6 ml/kg LBW, Gelofusine™, Fresenius Kabi AB, Sweden) or control (no preoperative fluids) before standardized TCI- induction of anesthesia. No other intravenous fluids before anesthesia induction.
Preoperative screening of biventricular systolic and diastolic function of the heart and level of venous return is implemented by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A consecutive cohort. Signed informed consent is gathered. Non-blinded randomization is conducted to fluid therapy before anesthesia induction. Preoperative diagnostics by echocardiography is conducted to all participants.Two arms, with or without preoperative fluids, are studied regarding hemodynamic stability during anesthesia induction.
| Arm | Type | Receives |
|---|---|---|
| Preoperative echo + fluids | Experimental | Other: Preoperative colloid fluid bolus (Gelofusine), Diagnostic Test: Preoperative transthoracic echocardiography20 individuals investigated by preoperative transthoracic echocardiography. Preoperative colloid fluid bolus (Gelofusine, Fresenius Kabi AB, Sweden) 6 ml/kg lean body weight, is infused intravenously immediately before anesthesia induction. |
| Preoperative echo, control | Active comparator | Diagnostic Test: Preoperative transthoracic echocardiography20 individuals investigated by preoperative transthoracic echocardiography. No intravenous fluids are infused before anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18 years
- body mass index ≤ 35 kg/m2
- electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery
Key exclusion criteria (7 listed)
- instable angina pectoris
- severe bronchial asthma
- severe COPD
- dementia
- severe heart valve disease
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 |
|---|---|---|
| Preoperative colloid fluid bolus (Gelofusine)Preoperative colloid fluid bolus | Other | Preoperative echo + fluids |
| Preoperative transthoracic echocardiographyScreening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction. | Diagnostic test | Preoperative echo + fluids, Preoperative echo, control |
Primary outcome
Incidence of blood pressure drops
Time frame: 20 minutes post anesthesia induction
Blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction .
Incidence of severe blood pressure drops
Time frame: 20 minutes post anesthesia induction
Blood pressure drop below mean arterial pressure at 55 mmHg during anesthesia induction. Non-invasive blood pressures (systolic, mean and diastolic) are measured 5 minutes before anesthesia induction and thereafter every 5 minutes post-induction.
3 secondary outcomes
Venous return and hemodynamic stability
Time frame: 20 minutes post anesthesia induction
Systolic heart failure and hemodynamic stability
Time frame: 20 minutes post anesthesia induction
Diastolic dysfunction and hemodynamic stability
Time frame: 20 minutes post anesthesia induction
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 16 Dec 2021.
- 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.
Tomi Myrberg, MD PhD principal investigator
Umea Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative colloid fluid bolus (Gelofusine) and Preoperative transthoracic echocardiography in people with Hemodynamic Instability and Anesthesia; Adverse Effect, run by Umeå University at 1 site in Sweden.
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 7 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 16 Dec 2021. 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 Sweden. 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.
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?
Incidence of blood pressure drops (time frame: 20 minutes post anesthesia induction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2021.