HypovolemiaNCT03644654
Perioperative Fluid Therapy Optimization in Spinal Surgery
A study testing Noninvasive monitoring group in people with Hypovolemia and Hypervolemia, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypovolemia, Hypervolemia
- What is being tested?
- Noninvasive monitoring group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Aug 2018to 30 Jul 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma scale 15
- ASA Physical Status Classification System I-III
- planed spinal surgery to 3 hours
- postoperative awakening
- sinus rhythm
Who cannot join
- NYHA III, IV
- BMI over 40 in females and over 35 in men
- awake operation
- postoperative artificial ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.
Read the detailed description
The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
- Conditions
- Hypovolemia, Hypervolemia
- Being tested
- Standard care group, Noninvasive monitoring group
- Keywords
- fluid responsiveness, haemodynamical monitoring, ClearSight
- Medical subject headings
- Hypovolemia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care groupProcedure or surgery
Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).
Noninvasive monitoring groupProcedure or surgery
Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | Active comparator | Fluid management will be done according standard care Receives: Procedure: Standard care group |
| Noninvasive monitoring group | Experimental | Fluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards) Receives: Procedure: Noninvasive monitoring group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative fluid balance
the difference between fluid intake and output and losses during surgery
Measured: 5 hours
Secondary outcomes (4)
mean dose of norepinephrine
mean dose of norepinephrine wil be calculated as total intraoperative norepinephrine dose devided by the lenght of surgery
Measured: 5 hours
level of creatinine
plasma level of creatinine measured on the first postoperative day
Measured: 24 hours
pooperative lung dysfunction
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy for more than 6 hours postoperatively
Measured: 24 hours
the length of postoperative stay
the length of postoperative stay in hospital
Measured: till 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start21 Aug 2018
- Primary completion30 Apr 2020
- Study completion30 Jul 2020
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 HypovolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Pavel Dostal, MD, Ph.D., Study director, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644654
- Sponsor's protocol ID
- UHospital Hradec Kralove
- Status last verified
- Nov 2022
- First submitted
- 21 Aug 2018
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kukralova L, Dostalova V, Cihlo M, Kraus J, Dostal P. The Impact of Individualized Hemodynamic Management on Intraoperative Fluid Balance and Hemodynamic Interventions during Spine Surgery in the Prone Position: A Prospective Randomized Trial. Medicina (Kaunas). 2022 Nov 20;58(11):1683. doi: 10.3390/medicina58111683.
PubMed 36422222
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method
- ClinicalTrials.gov ID
- NCT03644654
- Acronym / sponsor ID
- UHospital Hradec Kralove
- Conditions
- Hypovolemia, Hypervolemia
- Keywords
- fluid responsiveness, haemodynamical monitoring, ClearSight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 23 Aug 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 decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using continuous noninvasive cardiac output measurement with standard perioperative fluid management.
Detailed description
The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | Active comparator | Procedure: Standard care groupFluid management will be done according standard care |
| Noninvasive monitoring group | Experimental | Procedure: Noninvasive monitoring groupFluid management will be provided using noninvasive hemodynamical monitor ClearSight (Edwards) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Glasgow Coma scale 15
- ASA Physical Status Classification System I-III
- planed spinal surgery to 3 hours
- postoperative awakening
- sinus rhythm
Key exclusion criteria (4 listed)
- NYHA III, IV
- BMI over 40 in females and over 35 in men
- awake operation
- postoperative artificial ventilation
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 |
|---|---|---|
| Standard care groupPatient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug). | Procedure or surgery | Standard care group |
| Noninvasive monitoring groupPatient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards). | Procedure or surgery | Noninvasive monitoring group |
Primary outcome
intraoperative fluid balance
Time frame: 5 hours
the difference between fluid intake and output and losses during surgery
4 secondary outcomes
mean dose of norepinephrine
Time frame: 5 hours
level of creatinine
Time frame: 24 hours
pooperative lung dysfunction
Time frame: 24 hours
the length of postoperative stay
Time frame: till 2 months after surgery
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 30 Nov 2022.
- Results publication: PubMed 36422222Kukralova L, Dostalova V, Cihlo M, Kraus J, Dostal P. The Impact of Individualized Hemodynamic Management on Intraoperative Fluid Balance and Hemodynamic Interventions during Spine Surgery in the Prone Position: A Prospective Randomized Trial. Medicina (Kaunas). 2022 Nov 20;58(11):1683. doi: 10.3390/medicina58111683.
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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.
Pavel Dostal, MD, Ph.D. study director
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive monitoring group in people with Hypovolemia and Hypervolemia, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 5 inclusion and 4 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 30 Nov 2022. 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 Czechia. 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?
intraoperative fluid balance (time frame: 5 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 NCT03644654, 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 30 Nov 2022.