Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

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: Recruiting
• Conditions: Hepatic Ischemia
• Intervention / Treatment: Drug: sodium bicarbonate Ringer's solution

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shijiang Liu; Phone Number: 02568303569; Email: liushijiang@jsph.org.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Shijiang Liu
      • Contact: Shijiang Liu, MD; Phone Number: +86-25-68303569; Email: liushijiang@jsph.org.cn
      • Contact: Shijiang Liu, MD; Email: liushijiang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
lactic values	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

Outcome Measure	Measure Description	Time Frame
Amount of sodium bicarbonate injection (ml)		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		From the start of operation until the end of operation (during the operation).
Concentration of HCO3-		From the start of operation until the end of operation (during the operation).
Value of BE		From the start of operation until the end of operation (during the operation).
Concentration of Glucose		From the start of operation until the end of operation (during the operation).
Value of MAP		From the start of operation until the end of operation (during the operation).
Value of HR		From the start of operation until the end of operation (during the operation).
Concentration of CI		From the start of operation until the end of operation (during the operation).
Value of SVV		From the start of operation until the end of operation (during the operation).
Value of SVR		From the start of operation until the end of operation (during the operation).
Value of PPV		From the start of operation until the end of operation (during the operation).
Amount of norepinephrine		From the start of operation until the end of operation (during the operation).
Amount of phenylephrine		From the start of operation until the end of operation (during the operation).
Amount of ephedrine		From the start of operation until the end of operation (during the operation).
Amount of nitroglycerin		From the start of operation until the end of operation (during the operation).
Amount of milrinone		From the start of operation until the end of operation (during the operation).
Amount of furosemide		From the start of operation until the end of operation (during the operation).
time of palinesthesia from general anesthsia	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		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		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		day 1 and day 3 after surgery.
Concentration of Cr		day 1 and day 3 after surgery.
Value of AST		day 1 and day 3 after surgery.
Value of ALT		day 1 and day 3 after surgery.
Amount of blood loss	amount of blood loss during the operation.	intraoperative
Amount of blood transfusion	amount of blood transfusion during the operation.	intraoperative
urinary output	amount of urinary output during the operation.	intraoperative
15-item quality of recovery scale scores (QoR-15)	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

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Shijiang Liu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Pharmaceutical Solutions
• Other Study ID 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