Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

November 26, 2023 updated by: Shijiang Liu, MD, The First Affiliated Hospital with Nanjing Medical University

The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy

Compared the effects of Sodium bicarbonate Ringer's solution and lactate Ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate Ringer's solution in Laparoscopic hepatectomy.

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

The study was a single-center prospective randomized controlled study. A total of 100 patients undergoing laparoscopic hepatectomy under general anesthesia were randomly divided into 2 groups: Group A, sodium bicarbonate Ringer's solution group(n=50); Group B, Lactate Ringer's solution group (intraoperative crystal fluid dilatation was lactate ringer's injection, n=50); Collect patients' arterial blood gas, blood pressure, heart rate, peripheral vascular resistance, heart rate, blood vessels, the active drug usage, 5% sodium bicarbonate injection usage, inflammation factors, transaminase, creatinine, etc. with the point of preoperative (T0), during liver specimens resected(T1), after liver specimens resected(T2), and the end of surgery (T3). Then statistical analysis and observe the application prospect of sodium bicarbonate Ringer's injection in Laparoscopic hepatectomy.

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 (Estimated)

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.
100

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 Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years old,
  2. patients who plan to undergoing laparoscopic hepatectomy ;
  3. Willing to sign informed consent.

Exclusion Criteria:

  1. age <18 years
  2. pregnancy
  3. active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
  4. history of significant cerebrovascular disease
  5. restrictive or obstructive pulmonary disease
  6. uncontrolled hypertension
  7. renal dysfunction (glomerular filtration rate <60 mL/min),
  8. evidence of hepatic metabolic disorder (bilirubin >35 mmol/L)
  9. presence of active infection

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: Triple

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: Group A
Sodium bicarbonate Ringer's solution group
Drug: sodium bicarbonate Ringer's solution
Sodium bicarbonate Ringer's solution was used in Group A as intraoperative intravenous fluids. Lactate Ringer's solution was used in Group B as intraoperative intravenous fluids.
Other Names:
  • lactated Ringer's solution
Active Comparator: Group B
Lactate Ringer's solution group
Drug: sodium bicarbonate Ringer's solution
Sodium bicarbonate Ringer's solution was used in Group A as intraoperative intravenous fluids. Lactate Ringer's solution was used in Group B as intraoperative intravenous fluids.
Other Names:
  • lactated 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
lactic values
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
to compare the conditions of acid-base balance and internal environment between the two groups
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.

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
Amount of sodium bicarbonate injection (ml)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
Value of pH
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Concentration of HCO3-
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Value of BE
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Concentration of Glucose
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Value of MAP
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Value of HR
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Concentration of CI
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Value of SVV
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Value of SVR
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Value of PPV
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Amount of norepinephrine
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Amount of phenylephrine
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Amount of ephedrine
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Amount of nitroglycerin
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Amount of milrinone
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
Amount of furosemide
Time Frame: From the start of operation until the end of operation (during the operation).
From the start of operation until the end of operation (during the operation).
time of palinesthesia from general anesthsia
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
postoperative palinesthesia, recovering time
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
time of stay in PACU
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
extubation time
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.
Concentration of BUN
Time Frame: day 1 and day 3 after surgery.
day 1 and day 3 after surgery.
Concentration of Cr
Time Frame: day 1 and day 3 after surgery.
day 1 and day 3 after surgery.
Value of AST
Time Frame: day 1 and day 3 after surgery.
day 1 and day 3 after surgery.
Value of ALT
Time Frame: day 1 and day 3 after surgery.
day 1 and day 3 after surgery.
Amount of blood loss
Time Frame: intraoperative
amount of blood loss during the operation.
intraoperative
Amount of blood transfusion
Time Frame: intraoperative
amount of blood transfusion during the operation.
intraoperative
urinary output
Time Frame: intraoperative
amount of urinary output during the operation.
intraoperative
15-item quality of recovery scale scores (QoR-15)
Time Frame: day 1 and day 3 after surgery.
15-item quality of recovery scale scores. the minimum value is 0 and maximum value is 150, and whether higher scores mean a better outcome.
day 1 and day 3 after surgery.

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.
The First Affiliated Hospital with Nanjing Medical 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.
  • Principal Investigator: Shijiang Liu, The First Affiliated Hospital with Nanjing Medical 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.
February 1, 2022

Primary Completion (Estimated)

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.
July 1, 2024

Study Completion (Estimated)

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.
September 30, 2024

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).
February 27, 2023

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.
April 25, 2023

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.
April 26, 2023

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.
November 28, 2023

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.
November 26, 2023

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.
November 1, 2023

More Information

Terms related to this study

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.
  • 2021-SR-386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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