Jugular VeinsNCT04761237
The Value of Central Venous-arterial Carbon Dioxide Difference
A study testing Goal-directed fluid therapy (GDET) in people with Jugular Veins and Radial Artery, run by Liang Bing.
Trial summary
By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Jugular Veins, Radial Artery, Carbon Dioxide
- What is being tested?
- Goal-directed fluid therapy (GDET)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Dec 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASAI-II
- New York Heart Association classification of cardiac function I-II
- Estimated time of operation<3h
- The circulatory system of patients is stable after thrapy：CVP8～12 mmHg；MAP≥65 mmHg；urine volume>0.5m1/kg/ h；ScvO2：≥70％。
Who cannot join
- Anesthetic drug allergy or contraindication
- Patients with cardiopulmonary system disease、cardiopulmonary function abnormality、severe inhalation injuryand severe visceral injury.
About this study
Official title: A Research of Central Venous-arterial Carbon Dioxide Difference Has Guiding Significance for Severely Burn Patients in Liquid Resuscitation During Early Escharectomy
By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.
Read the detailed description
Objective: By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.
Methods: a prospective observational study was conducted on 145 patients with extensive burns admitted to surgical intensive care unit（SICU）of Guangzhou Red Cross hospital from January 2016 to December 2019. All patients received hemodynamic monitoring and goal-directed fluid therapy, patients with central venous oxygen saturation (ScvO2)< 70% were excluded. Patients were divided into the following groups according to the changing trend of Pcv-aCO2 between T base (before induction) and T 0h (after surgery) : group 1 (H-H) : Pcv-aCO2≥6mmHg between T base and T 0h. Group 2 (L-H) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h; Group 3 (H-L) : Pcv-aCO2≥6mmHg at T base and < 6mmHg at T 0h. Group 4( L-L) : Pcv-aCO2 < 6mmHg between T base and T0h.Postoperative basic physiological indicators such as heart rate（HR）, blood pressure, central venous pressure (CVP), cardiac output index (CI), Pcv-aCO2 and lactic acid were recorded at 0 and 18 hours after surgery. Oxygen dynamic indicators such as oxygen delivery index (DO2I), oxygen consumption index (VO2I), oxygen uptake rate (O2ER) and so on were calculated. Pearson correlation analysis was used to evaluate the correlation between Pcv-aCO2 and CI. The change of tissue perfusion and oxygenation with different levels of Pcv-aCO2 after fluid resuscitation were analyzed.
- Conditions
- Jugular Veins, Radial Artery, Carbon Dioxide
- Being tested
- Goal-directed fluid therapy (GDET)
- Keywords
- central venous-arterial carbon dioxide difference, liquid resuscitation, tissue perfusion and oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed fluid therapy (GDET)Drug
Compensatory dilatation was performed firstly and 5ml/kg crystal solution was added within 30min before induction of anesthesia.When SVV≥13%, infusion of colloidal solution 2ml/kg was performed 15-20 minutes.If the increase of SV was≥10% after the liquid impact and the SVV was still≥13%, the colloidal solution was used again for 2mL/kg and the infusion was maintained until the SVV < 13%.The infusion was stopped when the SVV < 10%.If the increase of SV was less than 10% or CI < 2.0L/min/m2 after infusion, dobutamine was given intravenously to observe the change of SV. If the increase of SV was greater than 10%, dobutamine could be maintained and the above fluid regimen continued.If the increase of SV was less than 10% and MAP≥65mmHg, the infusion of liquid was stopped and replaced with 4ml/kg/h infusion for maintenance.If the increase of SV was less than 10% and MAP was less than 65mmHg, the infusion was suspended.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | (H-P) : Pcv-aCO2≥6mmHg between T base and T 0h.; Receives: Drug: Goal-directed fluid therapy (GDET) |
| Group 2 | Experimental | (L-P) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h Receives: Drug: Goal-directed fluid therapy (GDET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central venous oxygen saturation
Central venous oxygen saturation in venous blood
Measured: From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Lactic acid value
Lactic acid level in arterial blood
Measured: From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jugular VeinsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liang Bing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liang Bing, Guangzhou Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761237
- Sponsor's protocol ID
- 2015-047-01
- Status last verified
- Feb 2021
- First submitted
- 19 Jan 2021
- Last updated
- 18 Feb 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research of Central Venous-arterial Carbon Dioxide Difference Has Guiding Significance for Severely Burn Patients in Liquid Resuscitation During Early Escharectomy
- ClinicalTrials.gov ID
- NCT04761237
- Acronym / sponsor ID
- 2015-047-01
- Conditions
- Jugular Veins, Radial Artery, Carbon Dioxide
- Keywords
- central venous-arterial carbon dioxide difference, liquid resuscitation, tissue perfusion and oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Liang BingUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Feb 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 Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.
Detailed description
Objective: By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.
Methods: a prospective observational study was conducted on 145 patients with extensive burns admitted to surgical intensive care unit（SICU）of Guangzhou Red Cross hospital from January 2016 to December 2019. All patients received hemodynamic monitoring and goal-directed fluid therapy, patients with central venous oxygen saturation (ScvO2)< 70% were excluded. Patients were divided into the following groups according to the changing trend of Pcv-aCO2 between T base (before induction) and T 0h (after surgery) : group 1 (H-H) : Pcv-aCO2≥6mmHg between T base and T 0h. Group 2 (L-H) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h; Group 3 (H-L) : Pcv-aCO2≥6mmHg at T base and < 6mmHg at T 0h. Group 4( L-L) : Pcv-aCO2 < 6mmHg between T base and T0h.Postoperative basic physiological indicators such as heart rate（HR）, blood pressure, central venous pressure (CVP), cardiac output index (CI), Pcv-aCO2 and lactic acid were recorded at 0 and 18 hours after surgery. Oxygen dynamic indicators such as oxygen delivery index (DO2I), oxygen consumption index (VO2I), oxygen uptake rate (O2ER) and so on were calculated. Pearson correlation analysis was used to evaluate the correlation between Pcv-aCO2 and CI. The change of tissue perfusion and oxygenation with different levels of Pcv-aCO2 after fluid resuscitation were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Goal-directed fluid therapy (GDET)(H-P) : Pcv-aCO2≥6mmHg between T base and T 0h.; |
| Group 2 | Experimental | Drug: Goal-directed fluid therapy (GDET)(L-P) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASAI-II
- New York Heart Association classification of cardiac function I-II
- Estimated time of operation<3h
- The circulatory system of patients is stable after thrapy：CVP8～12 mmHg；MAP≥65 mmHg；urine volume>0.5m1/kg/ h；ScvO2：≥70％。
Key exclusion criteria (2 listed)
- Anesthetic drug allergy or contraindication
- Patients with cardiopulmonary system disease、cardiopulmonary function abnormality、severe inhalation injuryand severe visceral injury.
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 fluid therapy (GDET)Compensatory dilatation was performed firstly and 5ml/kg crystal solution was added within 30min before induction of anesthesia.When SVV≥13%, infusion of colloidal solution 2ml/kg was performed 15-20 minutes.If the increase of SV was≥10% after the liquid impact and the SVV was still≥13%, the colloidal solution was used again for 2mL/kg and the infusion was maintained until the SVV < 13%.The infusion was stopped when the SVV < 10%.If the increase of SV was less than 10% or CI < 2.0L/min/m2 after infusion, dobutamine was given intravenously to observe the change of SV. If the increase of SV was greater than 10%, dobutamine could be maintained and the above fluid regimen continued.If the increase of SV was less than 10% and MAP≥65mmHg, the infusion of liquid was stopped and replaced with 4ml/kg/h infusion for maintenance.If the increase of SV was less than 10% and MAP was less than 65mmHg, the infusion was suspended. | Drug | Group 1, Group 2 |
Primary outcome
Central venous oxygen saturation
Time frame: From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Central venous oxygen saturation in venous blood
Lactic acid value
Time frame: From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Lactic acid level in arterial blood
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 18 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed fluid therapy (GDET) in people with Jugular Veins and Radial Artery, run by Liang Bing.
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 4 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 18 Feb 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?
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?
Central venous oxygen saturation (time frame: From start anesthesia until end of anesthesia, up to a maximum of 6 hours). 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 18 Feb 2021.