MicrocirculationNCT04982016
Effects of Fluid Therapy on Microcirculatory Reactivity
A study testing crystal therapy and colloid therapy in people with Microcirculation and Fluid Therapy, run by Beijing Anzhen Hospital.
Trial summary
Through preoperative fluid therapy, to investigate whether it can alleviate the microcirculation dysfunction after induction of anesthesia, and reduce the incidence of perioperative fluid therapy-related complications, thereby accelerating rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculation, Fluid Therapy
- What is being tested?
- crystal therapy and colloid therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Apr 2022
- 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 ≥ 18 years old
- Plan to undergo elective minimally invasive coronary artery bypass grafting (left anterior descending branch);
- Sign informed consent
Who cannot join
- Left ventricular ejection fraction <40%
- Diabetes
- Renal insufficiency (serum creatinine>177umol/L)
- Liver insufficiency (AST, ALT>3 times)
- Peripheral vascular disease
- Carotid artery stenosis (>60%) VOT test contraindications (arm deformity, burns, arteriovenous shunt)
- Use glucocorticoids, vasoactive drugs, inotropic drugs or intra-aortic balloon counterpulsation (IABP)
- Allergic to colloidal fluids
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Preoperative Fluid Therapy on Microcirculatory Reactivity in Patients With MIDCAB After General Anesthesia
Through preoperative fluid therapy, to investigate whether it can alleviate the microcirculation dysfunction after induction of anesthesia, and reduce the incidence of perioperative fluid therapy-related complications, thereby accelerating rehabilitation.
Read the detailed description
Patients undergoing minimally invasive coronary artery bypass graft surgery were randomly divided into crystal group, colloid group and control group. The preoperative fluid reactivity was evaluated according to the passive leg lifting test (PLR). When stroke volume increased (△SV)>16%, the patients in the crystal (carbonate Ringer solution) and the colloid group (hydroxyethyl starch solution) were treated with volume therapy, while the control group was not treated with PLR test and volume therapy. Vascular occlusion test was used to observe the effect of anesthesia induction on tissue oxygen saturation recovery slope (RecStO2) after volume therapy, Goal-directed fluid therapy was used during operation, and the postoperative microcirculation function and the incidence of related complications were observed.
- Conditions
- Microcirculation, Fluid Therapy
- Being tested
- crystal therapy, colloid therapy
- Keywords
- minimally invasive coronary artery bypass grafting, fuid therapy, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crystal therapyOther
Infusion of 250ml crystal solution before anesthesia induction
colloid therapyOther
Infusion of 250ml colloid solution before anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | There is no treatment before anesthesia induction. |
| Crystal group | Experimental | The fluid reactivity was determined by PLR test before anesthesia induction. The basic value was measured when maintain the head height at 45° for 2 min. and the liquid reactivity value was measured when both legs were raised 45° for 2 min. If △SV >16%, restore the head height to 45°, and 250ml carbonated Ringer's solution was infused (infusion time >10min). Receives: Other: crystal therapy |
| Colloidal group | Experimental | The fluid reactivity was determined by PLR test before anesthesia induction. The basic value was measured when maintain the head height at 45° for 2 min. and the liquid reactivity value was measured when both legs were raised 45° for 2 min. If △SV >16%, restore the head height to 45°, and 250ml colloidal fluid was infused (infusion time >10min). Receives: Other: colloid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DesStO2 is assessed
DesStO2(%/min):The downhill slope of StO2 reflects the oxygen consumption rate
Measured: The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Change in tM is assessed
The time for minimum value of StO2 to recover to maximum value of StO2
Measured: The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Secondary outcomes (6)
Change in mean arterial pressure is assessed
Measured: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Change in heart rate is assessed
Measured: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Length of hospital stay
Measured: up to 60 days
Duration of stay in the intensive care unit
Measured: up to 60 days
Change in HS is assessed
HS(ng/ml): As a valuable clinical biomarker for glycocalyx degradation
Measured: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Change in SDC-1 is assessed
SDC-1(ng/ml): As a valuable clinical biomarker for glycocalyx degradation
Measured: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study startSep 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boqun Cui, Beijing Anzhen Hospital
- Investigators
- Boqun Cui, Doctor, Principal investigator, Anzhen hospital Beijing China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982016
- Sponsor's protocol ID
- 2020093X
- Status last verified
- Sep 2021
- First submitted
- 24 Jun 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Fluid Therapy on Microcirculatory Reactivity in Patients With MIDCAB After General Anesthesia
- ClinicalTrials.gov ID
- NCT04982016
- Acronym / sponsor ID
- 2020093X
- Conditions
- Microcirculation, Fluid Therapy
- Keywords
- minimally invasive coronary artery bypass grafting, fuid therapy, microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 29 Jul 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.
Through preoperative fluid therapy, to investigate whether it can alleviate the microcirculation dysfunction after induction of anesthesia, and reduce the incidence of perioperative fluid therapy-related complications, thereby accelerating rehabilitation.
Detailed description
Patients undergoing minimally invasive coronary artery bypass graft surgery were randomly divided into crystal group, colloid group and control group. The preoperative fluid reactivity was evaluated according to the passive leg lifting test (PLR). When stroke volume increased (△SV)>16%, the patients in the crystal (carbonate Ringer solution) and the colloid group (hydroxyethyl starch solution) were treated with volume therapy, while the control group was not treated with PLR test and volume therapy. Vascular occlusion test was used to observe the effect of anesthesia induction on tissue oxygen saturation recovery slope (RecStO2) after volume therapy, Goal-directed fluid therapy was used during operation, and the postoperative microcirculation function and the incidence of related complications were observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –There is no treatment before anesthesia induction. |
| Crystal group | Experimental | Other: crystal therapyThe fluid reactivity was determined by PLR test before anesthesia induction. The basic value was measured when maintain the head height at 45° for 2 min. and the liquid reactivity value was measured when both legs were raised 45° for 2 min. If △SV >16%, restore the head height to 45°, and 250ml carbonated Ringer's solution was infused (infusion time >10min). |
| Colloidal group | Experimental | Other: colloid therapyThe fluid reactivity was determined by PLR test before anesthesia induction. The basic value was measured when maintain the head height at 45° for 2 min. and the liquid reactivity value was measured when both legs were raised 45° for 2 min. If △SV >16%, restore the head height to 45°, and 250ml colloidal fluid was infused (infusion time >10min). |
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 ≥ 18 years old
- Plan to undergo elective minimally invasive coronary artery bypass grafting (left anterior descending branch);
- Sign informed consent
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction <40%
- Diabetes
- Renal insufficiency (serum creatinine>177umol/L)
- Liver insufficiency (AST, ALT>3 times)
- Peripheral vascular 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 |
|---|---|---|
| crystal therapyInfusion of 250ml crystal solution before anesthesia induction | Other | Crystal group |
| colloid therapyInfusion of 250ml colloid solution before anesthesia induction | Other | Colloidal group |
Primary outcome
Change in DesStO2 is assessed
Time frame: The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
DesStO2(%/min):The downhill slope of StO2 reflects the oxygen consumption rate
Change in tM is assessed
Time frame: The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
The time for minimum value of StO2 to recover to maximum value of StO2
6 secondary outcomes
Change in mean arterial pressure is assessed
Time frame: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Change in heart rate is assessed
Time frame: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Length of hospital stay
Time frame: up to 60 days
Duration of stay in the intensive care unit
Time frame: up to 60 days
Change in HS is assessed
Time frame: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Change in SDC-1 is assessed
Time frame: 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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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.
Boqun Cui, Doctor principal investigator
Anzhen hospital Beijing China
Questions about this trial
What is this clinical trial studying?
A study testing crystal therapy and colloid therapy in people with Microcirculation and Fluid Therapy, run by Beijing Anzhen Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boqun Cui, Doctor (13811868848, 120053376@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DesStO2 is assessed (time frame: The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation). 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 8 Sep 2021.