Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

NCT05830136 | Recruiting

• 1 other identifier: 2021-SR-386
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• 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).

Study Arms (2)

Group A

EXPERIMENTAL

Sodium bicarbonate Ringer's solution group

Drug: sodium bicarbonate Ringer's solution

Group B

ACTIVE COMPARATOR

Lactate Ringer's solution group

Drug: sodium bicarbonate Ringer's solution

Interventions

sodium bicarbonate Ringer's solution 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.

Also known as: lactated Ringer's solution

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Shijiang Liu

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shijiang Liu

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shijiang Liu

CONTACT

02568303569; liushijiang@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 26, 2023
• Study Start: February 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)