search
Back to results

Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

Primary Purpose

Hepatic Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sodium bicarbonate Ringer's solution
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥18 years old, patients who plan to undergoing laparoscopic hepatectomy ; Willing to sign informed consent. Exclusion Criteria: age <18 years pregnancy active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure) history of significant cerebrovascular disease restrictive or obstructive pulmonary disease uncontrolled hypertension renal dysfunction (glomerular filtration rate <60 mL/min), evidence of hepatic metabolic disorder (bilirubin >35 mmol/L) presence of active infection

Sites / Locations

  • Shijiang LiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Sodium bicarbonate Ringer's solution group

Lactate Ringer's solution group

Outcomes

Primary Outcome Measures

lactic values
to compare the conditions of acid-base balance and internal environment between the two groups

Secondary Outcome Measures

Amount of sodium bicarbonate injection (ml)
Value of pH
Concentration of HCO3-
Value of BE
Concentration of Glucose
Value of MAP
Value of HR
Concentration of CI
Value of SVV
Value of SVR
Value of PPV
Amount of norepinephrine
Amount of phenylephrine
Amount of ephedrine
Amount of nitroglycerin
Amount of milrinone
Amount of furosemide
time of palinesthesia from general anesthsia
postoperative palinesthesia, recovering time
time of stay in PACU
extubation time
Concentration of BUN
Concentration of Cr
Value of AST
Value of ALT
Amount of blood loss
amount of blood loss during the operation.
Amount of blood transfusion
amount of blood transfusion during the operation.
urinary output
amount of urinary output during the operation.
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.

Full Information

First Posted
February 27, 2023
Last Updated
April 25, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05830136
Brief Title
Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy
Official Title
The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Sodium bicarbonate Ringer's solution group
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Lactate Ringer's solution group
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate Ringer's solution
Other Intervention Name(s)
lactated Ringer's solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
lactic values
Description
to compare the conditions of acid-base balance and internal environment between the two groups
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.
Secondary Outcome Measure Information:
Title
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.
Title
Value of pH
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Concentration of HCO3-
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Value of BE
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Concentration of Glucose
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Value of MAP
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Value of HR
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Concentration of CI
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Value of SVV
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Value of SVR
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Value of PPV
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Amount of norepinephrine
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Amount of phenylephrine
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Amount of ephedrine
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Amount of nitroglycerin
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Amount of milrinone
Time Frame
From the start of operation until the end of operation (during the operation).
Title
Amount of furosemide
Time Frame
From the start of operation until the end of operation (during the operation).
Title
time of palinesthesia from general anesthsia
Description
postoperative palinesthesia, recovering 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.
Title
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.
Title
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.
Title
Concentration of BUN
Time Frame
day 1 and day 3 after surgery.
Title
Concentration of Cr
Time Frame
day 1 and day 3 after surgery.
Title
Value of AST
Time Frame
day 1 and day 3 after surgery.
Title
Value of ALT
Time Frame
day 1 and day 3 after surgery.
Title
Amount of blood loss
Description
amount of blood loss during the operation.
Time Frame
intraoperative
Title
Amount of blood transfusion
Description
amount of blood transfusion during the operation.
Time Frame
intraoperative
Title
urinary output
Description
amount of urinary output during the operation.
Time Frame
intraoperative
Title
15-item quality of recovery scale scores (QoR-15)
Description
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.
Time Frame
day 1 and day 3 after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years old, patients who plan to undergoing laparoscopic hepatectomy ; Willing to sign informed consent. Exclusion Criteria: age <18 years pregnancy active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure) history of significant cerebrovascular disease restrictive or obstructive pulmonary disease uncontrolled hypertension renal dysfunction (glomerular filtration rate <60 mL/min), evidence of hepatic metabolic disorder (bilirubin >35 mmol/L) presence of active infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shijiang Liu
Phone
02568303569
Email
liushijiang@jsph.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shijiang Liu
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shijiang Liu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shijiang Liu, MD
Phone
+86-25-68303569
Email
liushijiang@jsph.org.cn
First Name & Middle Initial & Last Name & Degree
Shijiang Liu, MD
Email
liushijiang@njmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

We'll reach out to this number within 24 hrs