HyperlactacidemiaNCT04547296
Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy
A study testing Sodium Bicarbonate Ringer's Solution in people with Hyperlactacidemia, run by First Affiliated Hospital Xi'an Jiaotong University at 7 sites in China.
Trial summary
A variety of reasons lead to a sharp increase in lactic acid levels in patients undergoing liver resection, while leading to hyperlactic acidemia, resulting in decreased cardiac output, elevated blood potassium, and response to catecholamines and insulin Damage, increased risk of kidney damage, poor recovery of liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlactacidemia
- What is being tested?
- Sodium Bicarbonate Ringer's Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 7 sitesChina
- Study dates
- 28 Apr 2021to 30 Mar 2023
- 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
- Patients for selective liver surgery under general anesthesia
- Age > 18 year，BMI 18 - 40 kg/m2，American society of Anesthesiologists (ASA) grade are between I - III
- Ability to understand, sign informed consent and cooperate with the intervention and evaluation
Who cannot join
- Abnormal renal function：blood creatinine (Cr) and / or urea nitrogen (BUN)> upper limit of normal value; Patients with underlying kidney disease; patients with congenital kidney malformations.
- In patients with respiratory failure, arterial blood oxygen partial pressure (PaO2) < 60 mmHg, or accompanied by carbon dioxide partial pressure (PaCO2)> 50mmHg; blood oxygen saturation (SpO2) < 90%.
- A history of myocardial infarction within 6 months before the screening period; history of severe circulatory or respiratory diseases; history of autoimmune diseases; patients with mental illness or neurological disorders that cannot be expressed exactly; patients with a history of epilepsy; patients with pulmonary edema or congestive heart failure.
- Severe hypercalcemia (Ca2+ > 2.75 mmol/L), hypernatremia (Na+ > 155 mmol/L), hyperkalemia (K+ > 5.5 mmol/L), hyperchloremia (Cl- > 110 mmol/L), Hypermagnesium (Mg2+ > 1.25 mmol/L).
- Patients with a history of hypothyroidism; pregnant or lactating women.
- Patients with a history of adverse blood transfusion reactions; those who refuse blood transfusions.
- Participation in other clinical studies within 3 months before admission to this study.
- The investigator considers it unsuitable for inclusion.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 0931730000
Yatao Liu, MD, 0086-18152107860
Yatao Liu, MD
- Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 0991830001
Guiping Xu, PHD, 0086-13669988366
Guiping Xu, PHD
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 0991830054
Yi Hong, PHD, 0086-13009620188
Yi Hong, PHD
- Recruiting
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 029710068
Rui Yang, MD, 0086-13572135219
Rui Yang, MD
- Recruiting
Qinghai University Affiliated Hospita
Xining, Qinghai, 0971810001
Zhen Jia, MD, 0086-13519702706
Zhen Jia, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 0371450003
Xihua Lu, MD, 0086-18539965618
Xihua Lu, MD
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 0371450008
jiaqiang zhang, PHD, 0086-13937121360
jiaqiang zhang, PHD
About this study
Official title: Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy: a Multicenter, Randomized and Controlled Study
A variety of reasons lead to a sharp increase in lactic acid levels in patients undergoing liver resection, while leading to hyperlactic acidemia, resulting in decreased cardiac output, elevated blood potassium, and response to catecholamines and insulin Damage, increased risk of kidney damage, poor recovery of liver function, decreased immune function, and prolonged hospital stay. Sodium bicarbonate Ringer injection does not contain lactic acid. HCO3- is metabolized by acid-base neutralization in body fluids, and 90% is CO2 The form is excreted from the body by breathing, and only 10% HCO3- is metabolized by the kidney, without the burden of liver metabolism. Physiological concentration of Cl- avoids perchloric acidosis and kidney damage; physiological concentration of Ca2+ and Mg2+ help maintain the body's electrolyte balance and reduce stress-related arrhythmia.The smooth development of this study will help refine the intraoperative fluid management strategy, improve the patient's intraoperative tissue perfusion, maintain the body's acid-base and electrolyte balance, reduce postoperative kidney damage, and improve the patient's quality of life.
Read the detailed description
This study intends to carry out a high-quality clinical research with design specifications, large sample, multi-center, randomized and controlled methods. From October 9, 2020 to October 9, 2022, participants undergoing hepatectomy surgery under general anesthesia will be recruited. Participants will be randomly assigned, in a 1:1 ratio, to receive Sodium bicarbonate Ringer's solution or control (Acetate Ringer's solution). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. After entering the operating room, the two groups were pre-dilated with sodium bicarbonate Ringer or acetate Ringer (30 min, 8 ml/kg). After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas index (but are not limited to these data) at intraoperative will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 1 month.
- Conditions
- Hyperlactacidemia
- Being tested
- Sodium Bicarbonate Ringer's Solution
- Keywords
- hyperlactacidemia, Sodium bicarbonate Ringer's solution, Acetate Ringer's solution, hepatectomy
- Medical subject headings
- Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate Ringer's SolutionDrug
Also called Acetate Ringer's Solution
After the participants enter the operating room, radial artery puncture and catheterization were performed. The blood gas in the non-oxygen state was used as the basic value. A peripheral venous access was established in one upper limb, and the two groups were pre-dilated with sodium bicarbonate Ringer's solution or acetate Ringer's solution (30 min, 8 ml/kg). For laparoscopic surgery, adjust the PaCO2 value to 35-45 mmHg again 10 minutes after the establishment of the pneumoperitoneum. After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas was measured every hour after tracheal intubation during the operation, and the last blood gas was measured when the skin was sutured. When the blood gas pH <7.2, 5% sodium bicarbonate injection was given to correct it.
| Study group | Role | What they receive |
|---|---|---|
| BRS group | Experimental | After entering the operating room, this group were pre-dilated with sodium bicarbonate ringer's solution (30 min, 8 ml/kg), and maintained with 4-5 ml/kg/h sodium bicarbonate ringer's solution during the operation. Receives: Drug: Sodium Bicarbonate Ringer's Solution |
| ARS group | Experimental | After entering the operating room, this group were pre-dilated with acetate ringer ringer's solution (30 min, 8 ml/kg), and maintained with 4-5 ml/kg/h acetate ringer's solution during the operation. Receives: Drug: Sodium Bicarbonate Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hyperlactacidemia
Diagnostic criteria: Lac ≥ 2 mmol/L, pH ≤ 7.35, HCO3- ≤ 20 mmol/L, PaCO2 <50 mmHg
Measured: During the operation
Secondary outcomes (3)
The incidence of blood gas index disorder
Blood gas was monitored every hour during the operation and the incidence of intraoperative blood gas index disorder was recorded
Measured: During the operation
Incidence of postoperative acute kidney injury
The incidence of acute kidney injury within 48h after surgery was recorded
Measured: Day 2 after the operation
Rate of postoperative complications
postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications
Measured: Day 30 after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start28 Apr 2021
- Primary completion9 Oct 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlactacidemiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Henan Cancer Hospital, LanZhou University, Affiliated Hospital of Qinghai University, Shaanxi Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region
- Responsible party
- Sponsor
- Investigators
- Qiang Wang, PHD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547296
- Sponsor's protocol ID
- XJTU1AF2020LSK-071
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2020
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy: a Multicenter, Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT04547296
- Acronym / sponsor ID
- XJTU1AF2020LSK-071
- Conditions
- Hyperlactacidemia
- Keywords
- hyperlactacidemia, Sodium bicarbonate Ringer's solution, Acetate Ringer's solution, hepatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Henan Cancer Hospital, LanZhou University, Affiliated Hospital of Qinghai University, Shaanxi Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 9 Oct 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 14 Sep 2020 (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.
A variety of reasons lead to a sharp increase in lactic acid levels in patients undergoing liver resection, while leading to hyperlactic acidemia, resulting in decreased cardiac output, elevated blood potassium, and response to catecholamines and insulin Damage, increased risk of kidney damage, poor recovery of liver function, decreased immune function, and prolonged hospital stay. Sodium bicarbonate Ringer injection does not contain lactic acid. HCO3- is metabolized by acid-base neutralization in body fluids, and 90% is CO2 The form is excreted from the body by breathing, and only 10% HCO3- is metabolized by the kidney, without the burden of liver metabolism. Physiological concentration of Cl- avoids perchloric acidosis and kidney damage; physiological concentration of Ca2+ and Mg2+ help maintain the body's electrolyte balance and reduce stress-related arrhythmia.The smooth development of this study will help refine the intraoperative fluid management strategy, improve the patient's intraoperative tissue perfusion, maintain the body's acid-base and electrolyte balance, reduce postoperative kidney damage, and improve the patient's quality of life.
Detailed description
This study intends to carry out a high-quality clinical research with design specifications, large sample, multi-center, randomized and controlled methods. From October 9, 2020 to October 9, 2022, participants undergoing hepatectomy surgery under general anesthesia will be recruited. Participants will be randomly assigned, in a 1:1 ratio, to receive Sodium bicarbonate Ringer's solution or control (Acetate Ringer's solution). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. After entering the operating room, the two groups were pre-dilated with sodium bicarbonate Ringer or acetate Ringer (30 min, 8 ml/kg). After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas index (but are not limited to these data) at intraoperative will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRS group | Experimental | Drug: Sodium Bicarbonate Ringer's SolutionAfter entering the operating room, this group were pre-dilated with sodium bicarbonate ringer's solution (30 min, 8 ml/kg), and maintained with 4-5 ml/kg/h sodium bicarbonate ringer's solution during the operation. |
| ARS group | Experimental | Drug: Sodium Bicarbonate Ringer's SolutionAfter entering the operating room, this group were pre-dilated with acetate ringer ringer's solution (30 min, 8 ml/kg), and maintained with 4-5 ml/kg/h acetate ringer's solution during the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients for selective liver surgery under general anesthesia
- Age > 18 year，BMI 18 - 40 kg/m2，American society of Anesthesiologists (ASA) grade are between I - III
- Ability to understand, sign informed consent and cooperate with the intervention and evaluation
Key exclusion criteria (8 listed)
- Abnormal renal function：blood creatinine (Cr) and / or urea nitrogen (BUN)> upper limit of normal value; Patients with underlying kidney disease; patients with congenital kidney malformations.
- In patients with respiratory failure, arterial blood oxygen partial pressure (PaO2) < 60 mmHg, or accompanied by carbon dioxide partial pressure (PaCO2)> 50mmHg; blood oxygen saturation (SpO2) < 90%.
- A history of myocardial infarction within 6 months before the screening period; history of severe circulatory or respiratory diseases; history of autoimmune diseases; patients with mental illness or neurological disorders that cannot be expressed exactly; patients with a history of epilepsy; patients with pulmonary edema or congestive heart failure.
- Severe hypercalcemia (Ca2+ > 2.75 mmol/L), hypernatremia (Na+ > 155 mmol/L), hyperkalemia (K+ > 5.5 mmol/L), hyperchloremia (Cl- > 110 mmol/L), Hypermagnesium (Mg2+ > 1.25 mmol/L).
- Patients with a history of hypothyroidism; pregnant or lactating women.
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 |
|---|---|---|
| Sodium Bicarbonate Ringer's SolutionAlso: Acetate Ringer's SolutionAfter the participants enter the operating room, radial artery puncture and catheterization were performed. The blood gas in the non-oxygen state was used as the basic value. A peripheral venous access was established in one upper limb, and the two groups were pre-dilated with sodium bicarbonate Ringer's solution or acetate Ringer's solution (30 min, 8 ml/kg). For laparoscopic surgery, adjust the PaCO2 value to 35-45 mmHg again 10 minutes after the establishment of the pneumoperitoneum. After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas was measured every hour after tracheal intubation during the operation, and the last blood gas was measured when the skin was sutured. When the blood gas pH <7.2, 5% sodium bicarbonate injection was given to correct it. | Drug | ARS group, BRS group |
Primary outcome
Incidence of intraoperative hyperlactacidemia
Time frame: During the operation
Diagnostic criteria: Lac ≥ 2 mmol/L, pH ≤ 7.35, HCO3- ≤ 20 mmol/L, PaCO2 <50 mmHg
3 secondary outcomes
The incidence of blood gas index disorder
Time frame: During the operation
Incidence of postoperative acute kidney injury
Time frame: Day 2 after the operation
Rate of postoperative complications
Time frame: Day 30 after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Related trials for Hyperlactacidemia
Active, not recruiting
A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
Sepsis, Sepsis Bacterial
RecruitingObservational study
Effect of Preoperative Prewarming on Serum Lactate Levels in Patients Undergoing Elective Nephrectomy
Nephrectomy / Methods, Intraoperative Hypothermia
Recruiting
Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy
Prostate Cancer, Surgery
Recruiting
Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
Hyperlactatemia, Metabolic Syndrome (MetS)
Not yet recruitingObservational study
Submental Tissue Oxygenation and Arterial Lactate in Major Surgery
Microcirculatory Dysfunction, Tissue Hypoperfusion
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.
Qiang Wang, PHD study chair
First Affiliated Hospital Xi'an Jiaotong University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate Ringer's Solution in people with Hyperlactacidemia, run by First Affiliated Hospital Xi'an Jiaotong University at 7 sites 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 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 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Gao, PHD (0086-15209225834, gaowei2906@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hyperlactacidemia (time frame: During the operation). 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 19 Aug 2021.