Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

NCT ID: NCT05830136

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2026-05-01

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.

Conditions

Hepatic Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

Sodium bicarbonate Ringer's solution group

Group Type: EXPERIMENTAL

sodium bicarbonate Ringer's solution

Intervention Type: DRUG

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.

Group B

Lactate Ringer's solution group

Group Type: ACTIVE_COMPARATOR

sodium bicarbonate Ringer's solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

lactated Ringer's solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shijiang Liu, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shijiang Liu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Shijiang Liu

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shijiang Liu

Role: CONTACT

liushijiang@jsph.org.cn

02568303569

Facility Contacts

Shijiang Liu, MD

Role: primary

liushijiang@jsph.org.cn

+86-25-68303569

Shijiang Liu, MD

Role: backup

liushijiang@njmu.edu.cn

Other Identifiers

2021-SR-386

Identifier Type: -

Identifier Source: org_study_id