Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy

Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy: a Multicenter, Randomized and Controlled Study

A variety of reasons lead to a sharp increase in lactic acid levels in patients undergoing liver resection, while leading to hyperlactic acidemia, resulting in decreased cardiac output, elevated blood potassium, and response to catecholamines and insulin Damage, increased risk of kidney damage, poor recovery of liver function, decreased immune function, and prolonged hospital stay. Sodium bicarbonate Ringer injection does not contain lactic acid. HCO3- is metabolized by acid-base neutralization in body fluids, and 90% is CO2 The form is excreted from the body by breathing, and only 10% HCO3- is metabolized by the kidney, without the burden of liver metabolism. Physiological concentration of Cl- avoids perchloric acidosis and kidney damage; physiological concentration of Ca2+ and Mg2+ help maintain the body's electrolyte balance and reduce stress-related arrhythmia.The smooth development of this study will help refine the intraoperative fluid management strategy, improve the patient's intraoperative tissue perfusion, maintain the body's acid-base and electrolyte balance, reduce postoperative kidney damage, and improve the patient's quality of life.

Study Overview

• Status: Recruiting
• Conditions: Hyperlactacidemia
• Intervention / Treatment: Drug: Sodium Bicarbonate Ringer's Solution

Detailed Description

This study intends to carry out a high-quality clinical research with design specifications, large sample, multi-center, randomized and controlled methods. From October 9, 2020 to October 9, 2022, participants undergoing hepatectomy surgery under general anesthesia will be recruited. Participants will be randomly assigned, in a 1:1 ratio, to receive Sodium bicarbonate Ringer's solution or control (Acetate Ringer's solution). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. After entering the operating room, the two groups were pre-dilated with sodium bicarbonate Ringer or acetate Ringer (30 min, 8 ml/kg). After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas index (but are not limited to these data) at intraoperative will be recorded. At the same time, other dates will be recorded.The participation of each patient is scheduled for 1 month.

• Study Type: Interventional
• Enrollment (Anticipated): 484
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Gao, PHD; Phone Number: 0086-15209225834; Email: gaowei2906@xjtufh.edu.cn
• Study Contact Backup: Name: Qiang Wang, PHD; Phone Number: 0086-18049286968; Email: dr.wangqiang@139.com

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 0931730000
      • Recruiting
      • The First Hospital of Lanzhou University
      • Contact: Yatao Liu, MD; Phone Number: 0086-18152107860
      • Sub-Investigator: Yatao Liu, MD
  • Henan
    • Zhengzhou, Henan, China, 0371450003
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Xihua Lu, MD; Phone Number: 0086-18539965618
      • Sub-Investigator: Xihua Lu, MD
    • Zhengzhou, Henan, China, 0371450008
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: jiaqiang zhang, PHD; Phone Number: 0086-13937121360
      • Sub-Investigator: jiaqiang zhang, PHD
  • Qinghai
    • Xining, Qinghai, China, 0971810001
      • Recruiting
      • Qinghai University Affiliated Hospita
      • Contact: Zhen Jia, MD; Phone Number: 0086-13519702706
      • Sub-Investigator: Zhen Jia, MD
  • Shaanxi
    • Xi'an, Shaanxi, China, 029710068
      • Recruiting
      • Shaanxi Provincial People's Hospital
      • Contact: Rui Yang, MD; Phone Number: 0086-13572135219
      • Sub-Investigator: Rui Yang, MD
  • Xinjiang
    • Ürümqi, Xinjiang, China, 0991830001
      • Recruiting
      • People's Hospital of Xinjiang Uygur Autonomous Region
      • Contact: Guiping Xu, PHD; Phone Number: 0086-13669988366
      • Sub-Investigator: Guiping Xu, PHD
    • Ürümqi, Xinjiang, China, 0991830054
      • Recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Yi Hong, PHD; Phone Number: 0086-13009620188
      • Sub-Investigator: Yi Hong, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients for selective liver surgery under general anesthesia
2. Age > 18 year，BMI 18 - 40 kg/m2，American society of Anesthesiologists (ASA) grade are between I - III
3. Ability to understand, sign informed consent and cooperate with the intervention and evaluation

Exclusion Criteria:

1. Abnormal renal function：blood creatinine (Cr) and / or urea nitrogen (BUN)> upper limit of normal value; Patients with underlying kidney disease; patients with congenital kidney malformations.
2. In patients with respiratory failure, arterial blood oxygen partial pressure (PaO2) < 60 mmHg, or accompanied by carbon dioxide partial pressure (PaCO2)> 50mmHg; blood oxygen saturation (SpO2) < 90%.
3. A history of myocardial infarction within 6 months before the screening period; history of severe circulatory or respiratory diseases; history of autoimmune diseases; patients with mental illness or neurological disorders that cannot be expressed exactly; patients with a history of epilepsy; patients with pulmonary edema or congestive heart failure.
4. Severe hypercalcemia (Ca2+ > 2.75 mmol/L), hypernatremia (Na+ > 155 mmol/L), hyperkalemia (K+ > 5.5 mmol/L), hyperchloremia (Cl- > 110 mmol/L), Hypermagnesium (Mg2+ > 1.25 mmol/L).
5. Patients with a history of hypothyroidism; pregnant or lactating women.
6. Patients with a history of adverse blood transfusion reactions; those who refuse blood transfusions.
7. Participation in other clinical studies within 3 months before admission to this study.
8. The investigator considers it unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRS group; After entering the operating room, this group were pre-dilated with sodium bicarbonate ringer's solution (30 min, 8 ml/kg), and maintained with 4-5 ml/kg/h sodium bicarbonate ringer's solution during the operation.	Drug: Sodium Bicarbonate Ringer's Solution; After the participants enter the operating room, radial artery puncture and catheterization were performed. The blood gas in the non-oxygen state was used as the basic value. A peripheral venous access was established in one upper limb, and the two groups were pre-dilated with sodium bicarbonate Ringer's solution or acetate Ringer's solution (30 min, 8 ml/kg). For laparoscopic surgery, adjust the PaCO2 value to 35-45 mmHg again 10 minutes after the establishment of the pneumoperitoneum. After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas was measured every hour after tracheal intubation during the operation, and the last blood gas was measured when the skin was sutured. When the blood gas pH <7.2, 5% sodium bicarbonate injection was given to correct it.; Other Names: Acetate Ringer's Solution
Experimental: ARS group; After entering the operating room, this group were pre-dilated with acetate ringer ringer's solution (30 min, 8 ml/kg), and maintained with 4-5 ml/kg/h acetate ringer's solution during the operation.	Drug: Sodium Bicarbonate Ringer's Solution; After the participants enter the operating room, radial artery puncture and catheterization were performed. The blood gas in the non-oxygen state was used as the basic value. A peripheral venous access was established in one upper limb, and the two groups were pre-dilated with sodium bicarbonate Ringer's solution or acetate Ringer's solution (30 min, 8 ml/kg). For laparoscopic surgery, adjust the PaCO2 value to 35-45 mmHg again 10 minutes after the establishment of the pneumoperitoneum. After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas was measured every hour after tracheal intubation during the operation, and the last blood gas was measured when the skin was sutured. When the blood gas pH <7.2, 5% sodium bicarbonate injection was given to correct it.; Other Names: Acetate Ringer's Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hyperlactacidemia	Diagnostic criteria: Lac ≥ 2 mmol/L, pH ≤ 7.35, HCO3- ≤ 20 mmol/L, PaCO2 <50 mmHg	During the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of blood gas index disorder	Blood gas was monitored every hour during the operation and the incidence of intraoperative blood gas index disorder was recorded	During the operation
Incidence of postoperative acute kidney injury	The incidence of acute kidney injury within 48h after surgery was recorded	Day 2 after the operation
Rate of postoperative complications	postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications	Day 30 after the operation

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: LanZhou University; Henan Cancer Hospital; Shaanxi Provincial People's Hospital; Henan Provincial People's Hospital; People's Hospital of Xinjiang Uygur Autonomous Region; First Affiliated Hospital of Xinjiang Medical University; Affiliated Hospital of Qinghai University
• Investigators: Study Chair: Qiang Wang, PHD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Anticipated): October 9, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: September 7, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: hepatectomy; hyperlactacidemia; Sodium bicarbonate Ringer's solution; Acetate Ringer's solution
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlactatemia; Pharmaceutical Solutions
• Other Study ID Numbers: XJTU1AF2020LSK-071

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No