HemodynamicsNCT04934761
Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop
A study testing Fluid challenge strategy and conventional strategy in people with Hemodynamics, run by Guangzhou Red Cross Hospital at 1 site in China.
Trial summary
By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Fluid challenge strategy and conventional strategy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 10 Jun 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASAI-II age 40- 70 weight 48 - 72 kg.
Who cannot join
- Body mass index >30 or <15 kg/m2 Valve heart disease Left ventricular ejection fraction (LVEF) is less than 50% History of lung disease Preoperative arrhythmic disorder Permanent pacemaker Need for mechanical heart Support, Severe extrinsic vascular disease Valve dysfunction OED monitoring probe insertion contraindications Patients with preoperative assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop-based Myocardial Contraction and Work
By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.
Read the detailed description
Objective:By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.
Methods:20 patients with total knee replacement were enrolled in this study. Capacity shock therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t) was measured and calculated using TEE and P(t) was acquired by the analysis of patients'radial artery pressure waveform. We set five time points of parameter acquisition: after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting P(t) and V(t) at each time point after the calibration of cardiac cycle.
- Conditions
- Hemodynamics
- Being tested
- Fluid challenge strategy, conventional strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challenge strategyProcedure or surgery
Patients received 2ml/kg of succinylateol gelatin within 10 min for fluid shock therapy after grouping, taking SVV as the management target. If SVV< 13% after shock therapy, the shock therapy was stopped and the infusion was maintained with 4ml/kg/h of crystal solution. If SVV ≥ 13% and ΔSV <10%, the individual would be excluded from the experiment. If SVV ≥ 13% but ΔSV≥10%, 2ml/kg of succinylateol gelatin was given again within 10 min for liquid shock therapy until SVV<13%, and 4ml/kg/h of crystal solution was maintained after reaching the target. If SVV≥ 13% after two shock treatments, they were excluded from the experiment. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.
conventional strategyProcedure or surgery
4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.
| Study group | Role | What they receive |
|---|---|---|
| capacity shock | Experimental | 2ml/kg succinylateol gelatin Receives: Procedure: Fluid challenge strategy |
| routine management | Other | conventional strategy Receives: Procedure: conventional strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ees
Ees（End-systole Elasticity，mmHg/ml）
Measured: Baseline，After induction
Ees
Ees（End-systole Elasticity，mmHg/ml）
Measured: Immediately after the intervention,complete of the first round of the fluid challenge
Ees
Arterial elasticity is an invasively determined parameter of arterial load that is inversely related to arterial compliance
Measured: Immediately after the intervention,complete of the second round of the fluid challenge
Ees
Ees（End-systole Elasticity，mmHg/ml）
Measured: 1h after the first fluid challenge
Ees
Ees（End-systole Elasticity，mmHg/ml）
Measured: At the end of surgery
SW
SW（Stroke Volume，mmHg·ml）
Measured: Baseline，after induction
SW
SW（Stroke Volume，mmHg·ml）
Measured: Immediately after the intervention,complete of the first round of the fluid challenge
SW
SW（Stroke Volume，mmHg·ml）
Measured: Immediately after the intervention,complete of the second round of the fluid challenge
SW
SW（Stroke Volume，mmHg·ml）
Measured: 1h after the first fluid challenge
SW
SW（Stroke Volume，mmHg·ml）
Measured: At the end of surgery
Ea
Ea(Arterial elasticity, mmHg·ml)
Measured: Baseline，after induction
Ea
Ea(Arterial elasticity, mmHg·ml)
Measured: Immediately after the intervention,complete of the first round of the fluid challenge
Ea
Ea(Arterial elasticity, mmHg·ml)
Measured: Immediately after the intervention,complete of the second round of the fluid challenge
Ea
Ea(Arterial elasticity, mmHg·ml)
Measured: 1h after the first fluid challenge
Ea
Ea(Arterial elasticity, mmHg·ml)
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jun 2020
- Primary completion1 May 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Bing, Guangzhou Red Cross Hospital
- Investigators
- Cao Yang, Study director, Guangzhou Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934761
- Sponsor's protocol ID
- 202103000022
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 22 Jun 2021
- Results posted
- 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 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop-based Myocardial Contraction and Work
- ClinicalTrials.gov ID
- NCT04934761
- Acronym / sponsor ID
- 202103000022
- Conditions
- Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Guangzhou Red Cross HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 22 Jun 2021 (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.
By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.
Detailed description
Objective:By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.
Methods:20 patients with total knee replacement were enrolled in this study. Capacity shock therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t) was measured and calculated using TEE and P(t) was acquired by the analysis of patients'radial artery pressure waveform. We set five time points of parameter acquisition: after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting P(t) and V(t) at each time point after the calibration of cardiac cycle.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capacity shock | Experimental | Procedure: Fluid challenge strategy2ml/kg succinylateol gelatin |
| routine management | Other | Procedure: conventional strategyconventional strategy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASAI-II age 40- 70 weight 48 - 72 kg.
Key exclusion criteria (1 listed)
- Body mass index >30 or <15 kg/m2 Valve heart disease Left ventricular ejection fraction (LVEF) is less than 50% History of lung disease Preoperative arrhythmic disorder Permanent pacemaker Need for mechanical heart Support, Severe extrinsic vascular disease Valve dysfunction OED monitoring probe insertion contraindications Patients with preoperative assessments
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 |
|---|---|---|
| Fluid challenge strategyPatients received 2ml/kg of succinylateol gelatin within 10 min for fluid shock therapy after grouping, taking SVV as the management target. If SVV< 13% after shock therapy, the shock therapy was stopped and the infusion was maintained with 4ml/kg/h of crystal solution. If SVV ≥ 13% and ΔSV <10%, the individual would be excluded from the experiment. If SVV ≥ 13% but ΔSV≥10%, 2ml/kg of succinylateol gelatin was given again within 10 min for liquid shock therapy until SVV<13%, and 4ml/kg/h of crystal solution was maintained after reaching the target. If SVV≥ 13% after two shock treatments, they were excluded from the experiment. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group. | Procedure or surgery | capacity shock |
| conventional strategy4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group. | Procedure or surgery | routine management |
Primary outcome
Ees
Time frame: Baseline，After induction
Ees（End-systole Elasticity，mmHg/ml）
Ees
Time frame: Immediately after the intervention,complete of the first round of the fluid challenge
Ees（End-systole Elasticity，mmHg/ml）
Ees
Time frame: Immediately after the intervention,complete of the second round of the fluid challenge
Arterial elasticity is an invasively determined parameter of arterial load that is inversely related to arterial compliance
Ees
Time frame: 1h after the first fluid challenge
Ees（End-systole Elasticity，mmHg/ml）
Ees
Time frame: At the end of surgery
Ees（End-systole Elasticity，mmHg/ml）
SW
Time frame: Baseline，after induction
SW（Stroke Volume，mmHg·ml）
SW
Time frame: Immediately after the intervention,complete of the first round of the fluid challenge
SW（Stroke Volume，mmHg·ml）
SW
Time frame: Immediately after the intervention,complete of the second round of the fluid challenge
SW（Stroke Volume，mmHg·ml）
SW
Time frame: 1h after the first fluid challenge
SW（Stroke Volume，mmHg·ml）
SW
Time frame: At the end of surgery
SW（Stroke Volume，mmHg·ml）
Ea
Time frame: Baseline，after induction
Ea(Arterial elasticity, mmHg·ml)
Ea
Time frame: Immediately after the intervention,complete of the first round of the fluid challenge
Ea(Arterial elasticity, mmHg·ml)
Ea
Time frame: Immediately after the intervention,complete of the second round of the fluid challenge
Ea(Arterial elasticity, mmHg·ml)
Ea
Time frame: 1h after the first fluid challenge
Ea(Arterial elasticity, mmHg·ml)
Ea
Time frame: At the end of surgery
Ea(Arterial elasticity, mmHg·ml)
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 22 Jun 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.
Cao Yang study director
Guangzhou Red Cross Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge strategy and conventional strategy in people with Hemodynamics, run by Guangzhou Red Cross Hospital at 1 site in China.
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 22 Jun 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 China. 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?
Ees (time frame: Baseline，After induction). The study lists 15 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 22 Jun 2021.