Laparoscopic HepatectomyEarly Phase 1NCT06210217
Effect of TEE-guided Non-fluid Limited Combined With Dobutamine on Hepatic Venous Blood Flow Spectrum
A Early Phase 1 study testing Dobutamine hydrochloride, Injectable and 0.9% normal saline in people with Laparoscopic Hepatectomy, run by Sichuan University at 1 site in China.
Trial summary
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group. In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Hepatectomy
- What is being tested?
- Dobutamine hydrochloride, Injectable and 0.9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 7 Apr 2024
- Phase
- Early Phase 1
- 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
- undergo laparoscopic partial liver resection at West China Hospital from February 2024 to April 2024
- aged 18 to 65 years
- BMI<30kg/m2
- liver function Child-pugh grade A to B
- American Society of Anesthesiologists（ASA）grade Ⅰto Ⅲ.
Who cannot join
- coronary heart disease
- heart valvular disease
- arrhythmia
- stroke history
- cirrhosis
- esophageal varices
Show all 9Show fewer
- esophageal disease, stomach disease, previous esophageal or gastric surgery history
- chronic kidney disease
- coagulation dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital
Chengdu, Sichuan, 610041
Peng Liang, Ph.D., 18980602201, liangpengwch@scu.edu.cn
About this study
Official title: Effect of Transesophageal Echocardiography-guided Non-fluid Limited Combined Dobutamine Strategy on Hepatic Venous Blood Flow Spectrum in Patients Undergoing Laparoscopic Hepatectomy: a Prospective Randomized Controlled Study
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group. In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, transesophageal echocardiography (TEE) will be used to monitor left ventricular end-diastolic volume (LVEDV) and stroke volume (SV). In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of low central venous pressure(LCVP), nitroglycerin can be used if necessary.
Read the detailed description
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group.
Dobutamine group: 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. The dose of dobutamine will be increased if the operating field grade exceeds Grade II. Monitoring LVEDV and SV with TEE to ensure preload: after admission, the patient will be given 3-4 mL /kg/h equilibrium fluid as background infusion. LVEDV and SV will be monitored using TEE every 30 minutes after anesthesia induction. If LVEDV<75mL or SV<45mL, 200mL colloidal fluid will be given within 5min.
Control group: 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed. According to the currently commonly used principle of LCVP, the fluid will be limited to 3-4 mL/kg/h after anesthesia induction. If the operating field grade exceeds Grade II, nitroglycerin will be injected intravenously for remedial purposes at a rate of 0.3-0.8μg/kg/min.
Dobutamine and nitroglycerin will be stopped after hemostasis, and the anesthesiologist will supplement the infusion according to his/her experience.
- Conditions
- Laparoscopic Hepatectomy
- Being tested
- Dobutamine hydrochloride, Injectable, 0.9% normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine hydrochloride, InjectableDrug
Also called Dobutamine group
In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. The dose of dobutamine will be increased if the operating field grade exceeds Grade II. Monitoring LVEDV and SV with TEE to ensure preload: after admission, the patient will be given 3-4 mL /kg/h equilibrium fluid as background infusion. LVEDV and SV will be monitored using TEE every 30 minutes after anesthesia induction. If LVEDV<75mL or SV<45mL, 200mL colloidal fluid will be given within 5min.
0.9% normal salineDrug
Also called Control group
In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed. According to the currently commonly used principle of LCVP, the fluid will be limited to 3-4 ml /kg/h after anesthesia induction. If the operating field grade exceeds Grade II, nitroglycerin will be injected intravenously for remedial purposes at a rate of 0.3-0.8μg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine group | Experimental | In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, TEE will be used to monitor LVEDV and SV. Receives: Drug: Dobutamine hydrochloride, Injectable |
| Control group | Placebo comparator | In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of LCVP, nitroglycerin can be used if necessary. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of hepatic venous blood flow spectrum
The method of TEE monitoring hepatic vein blood flow: The TEE probe will be inserted into the patient's esophagus near the gastric fundus to show the liver. Next the probe will be rotated to the right to show the short axis of the inferior vena cava and the hepatic vein. Then the probe angle will be adjusted to 30-40° to show the long axis of the inferior vena cava and the hepatic vein, and the junction of the inferior vena cava and the hepatic vein. To record the blood flow spectrum of the hepatic vein using pulsed Doppler ultrasound (PW mode), the sampling volume should be placed in the hepatic vein, approximately 1.5-2cm away from the inferior vena cava opening. The angle between the sound beam and the blood flow direction should be less than 30°.
The blood flow spectrum variation refers to the spectrum change measured at each time point relative to the basic spectrum after anesthesia induction.
Measured: Intraoperative (after anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
Secondary outcomes (15)
Intraoperative blood loss
Intraoperative blood loss can be calculated by adding the blood volume absorbed by gauze (8ml for small gauze, 25ml for medium gauze, and 50ml for large gauze) to the blood volume collected in the suction tank during the operation.
Measured: intraoperative (Operation starts until hemostasis is completed.)
Surgical field grade
Grade Ⅰ is defined as the inferior vena cava and hepatic veins are very relaxed, and the liver section has little blood seepage, which is very easy to operate.
Grade Ⅱ is defined as the inferior vena cava and hepatic vein are relaxed, and the liver section has less blood seepage, which is easy to operate.
Grade Ⅲ is defined as the inferior vena cava and hepatic vein are tense, and the liver section oozes more blood, which is difficult to operate.
Grade Ⅳ is defined as the inferior vena cava and hepatic vein are obviously tense, and the liver section oozes a lot of blood, which is very difficult to operate.
Measured: Intraoperative (When the liver parenchyma is transected after the pringle maneuver.)
The remedy rate
During hepatic parenchyma dissection, if the operating field grade is greater than grade II, the dobutamine dose (3-6 μg/kg/min) will be increased in the dobutamine group, and nitroglycerin (0.3-0.8μg /kg/min) will be added in the control group.
Measured: Intraoperative (The liver parenchyma is transected until hemostasis is completed.)
Duration of intraoperative hypotension
Intraoperative hypotension is defined as SBP<90mmHg, or MAP<60mmHg, or MAP/SBP decreasing greater than 20% of the baseline value during the perioperative period.
Measured: Intraoperative (From anesthesia induction to the patient leaving the operating room.)
Ejection fraction
The ejection fraction will be measured by M-mode ultrasonography on the transgastric short-axis section of the left ventricle using TEE, recording the average value of three cardiac cycles.
Measured: Intraoperative (anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
The dose of vasoactive drugs
When perioperative SBP<90mmHg or MAP< 65mmHg, vasoactive drugs will be administered by the anesthesiologist.
Measured: Intraoperative (From anesthesia induction to the patient leaving the operating room.)
Intraoperative urine volume
After anesthesia induction, all patients will undergo catheterization to record urine volume during the operation.
Measured: Intraoperative (anesthesia induction to the patient leaving the operating room.)
Lactic acid
Invasive blood pressure will be monitored by the radial artery after anesthesia induction, and blood gas analysis will be performed after anesthesia induction and hepatic parenchyma dissection.
Measured: Intraoperative (after anesthesia induction, liver parenchyma transection is completed.)
Length of operation
From the beginning to the end of the surgery.
Measured: Intraoperative (From the beginning to the end of the surgery.)
Loss of hemoglobin
Preoperative hemoglobin content minus the hemoglobin content on the third day after surgery equals hemoglobin loss.
Measured: Preoperative and the third day after surgery.
Loss of albumin
Preoperative albumin content minus the albumin content on the third day after surgery equals albumin loss.
Measured: Preoperative and the third day after surgery.
Postoperative liver function (TB, ALT, AST) levels
The liver function (TB, ALT, AST) levels after surgery.
Measured: The first and third day after surgery.
Incidence of AKI
AKI stage 1 is defined as serum creatinine(SCR) increases 1.5-2 times higher than the baseline.
AKI stage 2 is defined as SCR is 2-3 times higher than the baseline.
AKI stage 3 is defined as SCR increases by more than 3 times compared with the baseline.
Measured: Within 3 days after surgery
Incidence of postoperative pulmonary complications
Pulmonary complications include pulmonary infection, respiratory failure, and moderate or large pleural effusion.
Measured: Up to 7days after surgery.
Length of postoperative hospitalization
determined by the number of days from operation to discharge.
Measured: Up to 2 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion7 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HepatectomyStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the dobutamine group, TEE will guide fluid rehydration to ensure preload, and dobutamine will be injected intravenously. In the control group, fluid will be limited by the principle of LCVP and the same amount of normal saline will be injected intravenously.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liang，MD, West China Hospital
- Investigators
- Peng Liang, Ph.D., Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210217
- Sponsor's protocol ID
- 2023HX2017
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transesophageal Echocardiography-guided Non-fluid Limited Combined Dobutamine Strategy on Hepatic Venous Blood Flow Spectrum in Patients Undergoing Laparoscopic Hepatectomy: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06210217
- Acronym / sponsor ID
- 2023HX2017
- Conditions
- Laparoscopic Hepatectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 7 Apr 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group. In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, transesophageal echocardiography (TEE) will be used to monitor left ventricular end-diastolic volume (LVEDV) and stroke volume (SV). In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of low central venous pressure(LCVP), nitroglycerin can be used if necessary.
Detailed description
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group.
Dobutamine group: 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. The dose of dobutamine will be increased if the operating field grade exceeds Grade II. Monitoring LVEDV and SV with TEE to ensure preload: after admission, the patient will be given 3-4 mL /kg/h equilibrium fluid as background infusion. LVEDV and SV will be monitored using TEE every 30 minutes after anesthesia induction. If LVEDV<75mL or SV<45mL, 200mL colloidal fluid will be given within 5min.
Control group: 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed. According to the currently commonly used principle of LCVP, the fluid will be limited to 3-4 mL/kg/h after anesthesia induction. If the operating field grade exceeds Grade II, nitroglycerin will be injected intravenously for remedial purposes at a rate of 0.3-0.8μg/kg/min.
Dobutamine and nitroglycerin will be stopped after hemostasis, and the anesthesiologist will supplement the infusion according to his/her experience.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In the dobutamine group, TEE will guide fluid rehydration to ensure preload, and dobutamine will be injected intravenously. In the control group, fluid will be limited by the principle of LCVP and the same amount of normal saline will be injected intravenously.
| Arm | Type | Receives |
|---|---|---|
| Dobutamine group | Experimental | Drug: Dobutamine hydrochloride, InjectableIn the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, TEE will be used to monitor LVEDV and SV. |
| Control group | Placebo comparator | Drug: 0.9% normal salineIn the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of LCVP, nitroglycerin can be used if necessary. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- undergo laparoscopic partial liver resection at West China Hospital from February 2024 to April 2024
- aged 18 to 65 years
- BMI<30kg/m2
- liver function Child-pugh grade A to B
- American Society of Anesthesiologists（ASA）grade Ⅰto Ⅲ.
Key exclusion criteria (9 listed)
- coronary heart disease
- heart valvular disease
- arrhythmia
- stroke history
- cirrhosis
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 |
|---|---|---|
| Dobutamine hydrochloride, InjectableAlso: Dobutamine groupIn the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. The dose of dobutamine will be increased if the operating field grade exceeds Grade II. Monitoring LVEDV and SV with TEE to ensure preload: after admission, the patient will be given 3-4 mL /kg/h equilibrium fluid as background infusion. LVEDV and SV will be monitored using TEE every 30 minutes after anesthesia induction. If LVEDV<75mL or SV<45mL, 200mL colloidal fluid will be given within 5min. | Drug | Dobutamine group |
| 0.9% normal salineAlso: Control groupIn the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed. According to the currently commonly used principle of LCVP, the fluid will be limited to 3-4 ml /kg/h after anesthesia induction. If the operating field grade exceeds Grade II, nitroglycerin will be injected intravenously for remedial purposes at a rate of 0.3-0.8μg/kg/min. | Drug | Control group |
Primary outcome
Variation of hepatic venous blood flow spectrum
Time frame: Intraoperative (after anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
The method of TEE monitoring hepatic vein blood flow: The TEE probe will be inserted into the patient's esophagus near the gastric fundus to show the liver. Next the probe will be rotated to the right to show the short axis of the inferior vena cava and the hepatic vein. Then the probe angle will be adjusted to 30-40° to show the long axis of the inferior vena cava and the hepatic vein, and the junction of the inferior vena cava and the hepatic vein. To record the blood flow spectrum of the hepatic vein using pulsed Doppler ultrasound (PW mode), the sampling volume should be placed in the hepatic vein, approximately 1.5-2cm away from the inferior vena cava opening. The angle between the sound beam and the blood flow direction should be less than 30°. The blood flow spectrum variation refers to the spectrum change measured at each time point relative to the basic spectrum after anesthesia induction.
15 secondary outcomes
Intraoperative blood loss
Time frame: intraoperative (Operation starts until hemostasis is completed.)
Surgical field grade
Time frame: Intraoperative (When the liver parenchyma is transected after the pringle maneuver.)
The remedy rate
Time frame: Intraoperative (The liver parenchyma is transected until hemostasis is completed.)
Duration of intraoperative hypotension
Time frame: Intraoperative (From anesthesia induction to the patient leaving the operating room.)
Ejection fraction
Time frame: Intraoperative (anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
The dose of vasoactive drugs
Time frame: Intraoperative (From anesthesia induction to the patient leaving the operating room.)
Intraoperative urine volume
Time frame: Intraoperative (anesthesia induction to the patient leaving the operating room.)
Lactic acid
Time frame: Intraoperative (after anesthesia induction, liver parenchyma transection is completed.)
Length of operation
Time frame: Intraoperative (From the beginning to the end of the surgery.)
Loss of hemoglobin
Time frame: Preoperative and the third day after surgery.
Loss of albumin
Time frame: Preoperative and the third day after surgery.
Postoperative liver function (TB, ALT, AST) levels
Time frame: The first and third day after surgery.
Incidence of AKI
Time frame: Within 3 days after surgery
Incidence of postoperative pulmonary complications
Time frame: Up to 7days after surgery.
Length of postoperative hospitalization
Time frame: Up to 2 weeks after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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.
Peng Liang, Ph.D. study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dobutamine hydrochloride, Injectable and 0.9% normal saline in people with Laparoscopic Hepatectomy, run by Sichuan University 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 5 inclusion and 9 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 18 Jan 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Peng Liang, Ph.D. (18980602201, liangpengwch@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of hepatic venous blood flow spectrum (time frame: Intraoperative (after anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)). 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 Jan 2024.