HemodynamicsNCT05221788
Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns
A study testing Goal-directed hemodynamic therapy in people with Hemodynamics, run by Guangzhou Red Cross Hospital at 1 site in China.
Trial summary
To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Goal-directed hemodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the age is between 18 and 65 years old;
- the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA;
- patients will undergo the first operation after fluid resuscitation (after the shock period). The types of operation include incision decompression, escharectomy and skin grafting, and so on.
Who cannot join
- Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage.
- Patients or family members refusing informed consent for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial
To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
Read the detailed description
Objective: To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
Methods: Ninety-five patients with extensive burns undergoing early debridement grafting were randomly divided into a standard hemodynamic management group (control group) and a goal-directed hemodynamic therapy group (GDHT group), with the control group guided by conventional parameters and the GDHT group guided by SV based on Vigileo. The primary outcome were incidence of cardiac complications, pulmonary complications, neurological disease, acute kidney injury, and pain within 7 days postoperatively. Secondary outcome included microcirculatory perfusion metrics: Lactate (lac), The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2).
- Conditions
- Hemodynamics
- Being tested
- Goal-directed hemodynamic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed hemodynamic therapyProcedure or surgery
Compounded sodium lactate 3 ml/kg/h was given intravenously as a basal rehydration volume before induction, and 200 ml of electrolyte solution was given after induction. If SV increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but mean arterial pressure (MAP) <65 mmHg and/or cardiac index (CI) <2.5l/min/m2 give low-dose norepinephrine continuous pumping and/or dobutamine continuous pumping. If hypotension was accompanied by hypovolemia (defined as urine output <0.5 ml /kg/h and/or heart rate more than 20% above baseline), plasma was administered until urine output and/or HR returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability.
| Study group | Role | What they receive |
|---|---|---|
| GDHT(goal-directed hemodynamic therapy) | Experimental | Compounded sodium lactate 3 ml/kg/h was given intravenously as a basal rehydration volume before induction, and 200 ml of electrolyte solution was given after induction. If stroke volume (SV) increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but MAP <65 mmHg and/or cardiac index (CI) <2.5l/min/m2 give low-dose norepinephrine continuous pumping and/or dobutamine continuous pumping. If hypotension was accompanied by hypovolemia (defined as urine output <0.5 ml /kg/h and/or heart rate (HR) more than 20% above baseline), plasma was administered until urine output and/or heart rate returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability. Receives: Procedure: Goal-directed hemodynamic therapy |
| control | No intervention | Continuous infusion of compounded sodium lactate 5-7 ml/kg/h was allowed to receive colloidal solution, norepinephrine and dobutamine at the discretion of the anesthesiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac complications
Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation)
Measured: within 7 days postoperatively
Incidence of pulmonary complications
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)
Measured: within 7 days postoperatively
Incidence of neurological complications
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Measured: within 7 days postoperatively
Incidence of acute kidney injury
defined by acute kidney injury criteria.
Measured: within 7 days postoperatively
postoperative pain conditions
postoperative pain
Measured: within 7 days postoperatively
Secondary outcomes (12)
Blood lacate
an indicator related to microcirculation perfusion
Measured: before operation (T1)
Blood lacate
an indicator related to microcirculation perfusion
Measured: 1 hour into the operation (T2)
Blood lacate
an indicator related to microcirculation perfusion
Measured: 2 hours into the operation (T3)
Blood lactate
an indicator related to microcirculation perfusion
Measured: the end of operation (T4)
Blood lactate
an indicator related to microcirculation perfusion
Measured: 24 hours after operation (T5)
Blood lactate
an indicator related to microcirculation perfusion
Measured: 7 days after operation
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Measured: before operation (T1)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Measured: 1 hour into the operation (T2)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Measured: 2 hours into the operation (T3)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Measured: the end of operation (T4)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Measured: 24 hours after operation (T5)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
an indicator related to microcirculation perfusion
Measured: 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 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
- Yang Cao, Study director, Guangzhou RedCross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221788
- Sponsor's protocol ID
- 2020-079-02
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 3 Feb 2022
- 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 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns: a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05221788
- Acronym / sponsor ID
- 2020-079-02
- Conditions
- Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Guangzhou Red Cross HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Feb 2022 (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.
To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
Detailed description
Objective: To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.
Methods: Ninety-five patients with extensive burns undergoing early debridement grafting were randomly divided into a standard hemodynamic management group (control group) and a goal-directed hemodynamic therapy group (GDHT group), with the control group guided by conventional parameters and the GDHT group guided by SV based on Vigileo. The primary outcome were incidence of cardiac complications, pulmonary complications, neurological disease, acute kidney injury, and pain within 7 days postoperatively. Secondary outcome included microcirculatory perfusion metrics: Lactate (lac), The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDHT(goal-directed hemodynamic therapy) | Experimental | Procedure: Goal-directed hemodynamic therapyCompounded sodium lactate 3 ml/kg/h was given intravenously as a basal rehydration volume before induction, and 200 ml of electrolyte solution was given after induction. If stroke volume (SV) increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but MAP <65 mmHg and/or cardiac index (CI) <2.5l/min/m2 give low-dose norepinephrine continuous pumping and/or dobutamine continuous pumping. If hypotension was accompanied by hypovolemia (defined as urine output <0.5 ml /kg/h and/or heart rate (HR) more than 20% above baseline), plasma was administered until urine output and/or heart rate returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability. |
| control | No intervention | –Continuous infusion of compounded sodium lactate 5-7 ml/kg/h was allowed to receive colloidal solution, norepinephrine and dobutamine at the discretion of the anesthesiologist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the age is between 18 and 65 years old;
- the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA;
- patients will undergo the first operation after fluid resuscitation (after the shock period). The types of operation include incision decompression, escharectomy and skin grafting, and so on.
Key exclusion criteria (2 listed)
- Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage.
- Patients or family members refusing informed consent for this study.
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 |
|---|---|---|
| Goal-directed hemodynamic therapyCompounded sodium lactate 3 ml/kg/h was given intravenously as a basal rehydration volume before induction, and 200 ml of electrolyte solution was given after induction. If SV increased >10%, 200 ml of electrolyte solution was continued until SV increased <10%. After fluid shock, if SV increases <10% but mean arterial pressure (MAP) <65 mmHg and/or cardiac index (CI) <2.5l/min/m2 give low-dose norepinephrine continuous pumping and/or dobutamine continuous pumping. If hypotension was accompanied by hypovolemia (defined as urine output <0.5 ml /kg/h and/or heart rate more than 20% above baseline), plasma was administered until urine output and/or HR returned to normal. Fluid responsiveness and hemodynamic variables were reassessed at least every 15 minutes, and more frequently in cases of hemodynamic instability. | Procedure or surgery | GDHT(goal-directed hemodynamic therapy) |
Primary outcome
Incidence of cardiac complications
Time frame: within 7 days postoperatively
Incidence of cardiac complications within 7 days of surgery (myocardial infarction (electrocardiogram (ECG) and/or troponin T serum concentration; new-onset atrial fibrillation)
Incidence of pulmonary complications
Time frame: within 7 days postoperatively
Incidence of pulmonary complications (pneumonia, pulmonary edema, pleural effusion, oxygenation index <300)
Incidence of neurological complications
Time frame: within 7 days postoperatively
Incidence of Neurological Disorders within 7 days postoperatively (Stroke and Delirium)
Incidence of acute kidney injury
Time frame: within 7 days postoperatively
defined by acute kidney injury criteria.
postoperative pain conditions
Time frame: within 7 days postoperatively
postoperative pain
12 secondary outcomes
Blood lacate
Time frame: before operation (T1)
Blood lacate
Time frame: 1 hour into the operation (T2)
Blood lacate
Time frame: 2 hours into the operation (T3)
Blood lactate
Time frame: the end of operation (T4)
Blood lactate
Time frame: 24 hours after operation (T5)
Blood lactate
Time frame: 7 days after operation
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Time frame: before operation (T1)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Time frame: 1 hour into the operation (T2)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Time frame: 2 hours into the operation (T3)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Time frame: the end of operation (T4)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Time frame: 24 hours after operation (T5)
The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2)
Time frame: 7 days after operation
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 3 Feb 2022.
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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.
Yang Cao study director
Guangzhou RedCross 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 Goal-directed hemodynamic therapy 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 3 inclusion and 2 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 3 Feb 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 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?
Incidence of cardiac complications (time frame: within 7 days postoperatively). The study lists 5 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 3 Feb 2022.