Hemodynamic InstabilityNCT03394833
Hemodynamic Stability During Induction of Anaesthesia
A study testing gelofusine in people with Hemodynamic Instability and Fluid Therapy, run by Umeå University at 1 site in Sweden.
Trial summary
The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) 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, Fluid Therapy, Anesthesia; Adverse Effect
- What is being tested?
- gelofusine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 20 Nov 2017to 30 Apr 2019
- 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
- 80 individuals 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 at the day of surgery, severe bronchial asthma or COPD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study
The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.
Read the detailed description
40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.
NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.
- Being tested
- gelofusine
- Keywords
- preoperative, fluid therapy, hemodynamics, anesthesia induction, rapid sequence induction, TCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gelofusineOther
Also called colloid fluid
Preoperative colloid fluid bolus 6ml/kg ideal body weight
| Study group | Role | What they receive |
|---|---|---|
| Preoperative fluids | Experimental | 40 individuals receiving preoperative colloid fluid bolus at 6 ml/kg LBW, (Gelofusine™, Fresenius Kabi AB, Sweden) before anesthesia induction by TCI (n = 20) or RSI (n =20). Receives: Other: gelofusine |
| No preoperative fluids | No intervention | 40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids. |
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
Measured: 20 minutes post anesthesia induction
Effect of preoperative fluid bolus
Does preoperative fluid bolus decrease incidence of blood pressure drops
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 posted9 Jan 2018
- Study start20 Nov 2017
- Primary completion15 Dec 2018
- Study completion30 Apr 2019
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 Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Non-blinded randomization. Standardized method comparison.
- Masking
- None (open label)
- Enrolment
- 80 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 P Myrberg, MD PhD, Principal investigator, Umeå University, Norrbotten county concil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394833
- Sponsor's protocol ID
- 2016/361-31
- Status last verified
- Sep 2019
- First submitted
- 17 Nov 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myrberg T, Lindelof L, Hultin M. Effect of preoperative fluid therapy on hemodynamic stability during anesthesia induction, a randomized study. Acta Anaesthesiol Scand. 2019 Oct;63(9):1129-1136. doi: 10.1111/aas.13419. Epub 2019 Jun 26.
PubMed 31240711
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study
- ClinicalTrials.gov ID
- NCT03394833
- Acronym / sponsor ID
- 2016/361-31
- Keywords
- preoperative, fluid therapy, hemodynamics, anesthesia induction, rapid sequence induction, TCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 9 Jan 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 if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.
Detailed description
40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.
NIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded randomization. Standardized method comparison.
| Arm | Type | Receives |
|---|---|---|
| Preoperative fluids | Experimental | Other: gelofusine40 individuals receiving preoperative colloid fluid bolus at 6 ml/kg LBW, (Gelofusine™, Fresenius Kabi AB, Sweden) before anesthesia induction by TCI (n = 20) or RSI (n =20). |
| No preoperative fluids | No intervention | –40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 80 individuals 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 (1 listed)
- instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.
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 |
|---|---|---|
| gelofusineAlso: colloid fluidPreoperative colloid fluid bolus 6ml/kg ideal body weight | Other | Preoperative fluids |
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
Effect of preoperative fluid bolus
Time frame: 20 minutes post anesthesia induction
Does preoperative fluid bolus decrease incidence of blood pressure drops
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 26 Sep 2019.
- Derived from this study: PubMed 31240711Myrberg T, Lindelof L, Hultin M. Effect of preoperative fluid therapy on hemodynamic stability during anesthesia induction, a randomized study. Acta Anaesthesiol Scand. 2019 Oct;63(9):1129-1136. doi: 10.1111/aas.13419. Epub 2019 Jun 26.
- 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 P Myrberg, MD PhD principal investigator
Umeå University, Norrbotten county concil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gelofusine in people with Hemodynamic Instability and Fluid Therapy, 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 1 inclusion and 1 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 26 Sep 2019. 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?
On the ClinicalTrials.gov record for NCT03394833, 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 26 Sep 2019.