Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy

August 17, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
484

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 0931730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • Yatao Liu, MD
          • Phone Number: 0086-18152107860
        • Sub-Investigator:
          • Yatao Liu, MD
    • Henan
      • Zhengzhou, Henan, China, 0371450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Xihua Lu, MD
          • Phone Number: 0086-18539965618
        • Sub-Investigator:
          • Xihua Lu, MD
      • Zhengzhou, Henan, China, 0371450008
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • jiaqiang zhang, PHD
          • Phone Number: 0086-13937121360
        • Sub-Investigator:
          • jiaqiang zhang, PHD
    • Qinghai
      • Xining, Qinghai, China, 0971810001
        • Recruiting
        • Qinghai University Affiliated Hospita
        • Contact:
          • Zhen Jia, MD
          • Phone Number: 0086-13519702706
        • Sub-Investigator:
          • Zhen Jia, MD
    • Shaanxi
      • Xi'an, Shaanxi, China, 029710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • Rui Yang, MD
          • Phone Number: 0086-13572135219
        • Sub-Investigator:
          • Rui Yang, MD
    • Xinjiang
      • Ürümqi, Xinjiang, China, 0991830001
        • Recruiting
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
          • Guiping Xu, PHD
          • Phone Number: 0086-13669988366
        • Sub-Investigator:
          • Guiping Xu, PHD
      • Ürümqi, Xinjiang, China, 0991830054
        • Recruiting
        • The first affiliated hospital of Xinjiang medical university
        • Contact:
          • Yi Hong, PHD
          • Phone Number: 0086-13009620188
        • Sub-Investigator:
          • Yi Hong, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients for selective liver surgery under general anesthesia
  2. Age > 18 year，BMI 18 - 40 kg/m2，American society of Anesthesiologists (ASA) grade are between I - III
  3. Ability to understand, sign informed consent and cooperate with the intervention and evaluation

Exclusion Criteria:

  1. 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.
  2. 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%.
  3. 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.
  4. 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).
  5. Patients with a history of hypothyroidism; pregnant or lactating women.
  6. Patients with a history of adverse blood transfusion reactions; those who refuse blood transfusions.
  7. Participation in other clinical studies within 3 months before admission to this study.
  8. The investigator considers it unsuitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BRS group
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.
Drug: Sodium Bicarbonate 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.
Other Names:
  • Acetate Ringer's Solution
Experimental: ARS group
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.
Drug: Sodium Bicarbonate 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.
Other Names:
  • Acetate Ringer's Solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
During the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of blood gas index disorder
Time Frame: During the operation
Blood gas was monitored every hour during the operation and the incidence of intraoperative blood gas index disorder was recorded
During the operation
Incidence of postoperative acute kidney injury
Time Frame: Day 2 after the operation
The incidence of acute kidney injury within 48h after surgery was recorded
Day 2 after the operation
Rate of postoperative complications
Time Frame: Day 30 after the operation
postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications
Day 30 after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LanZhou University
Henan Cancer Hospital
Shaanxi Provincial People's Hospital
Henan Provincial People's Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
First Affiliated Hospital of Xinjiang Medical University
Affiliated Hospital of Qinghai University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Qiang Wang, PHD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJTU1AF2020LSK-071

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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