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

Last updated: August 17, 2021
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04547296
XJTU1AF2020LSK-071
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 arebetween I - III
  3. Ability to understand, sign informed consent and cooperate with the intervention andevaluation

Exclusion

Exclusion Criteria:

  1. Abnormal renal function：blood creatinine (Cr) and / or urea nitrogen (BUN)> upperlimit of normal value; Patients with underlying kidney disease; patients withcongenital 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; bloodoxygen 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 expressedexactly; patients with a history of epilepsy; patients with pulmonary edema orcongestive 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 bloodtransfusions.
  7. Participation in other clinical studies within 3 months before admission to thisstudy.
  8. The investigator considers it unsuitable for inclusion.

Study Design

Total Participants: 484
Study Start date:
April 28, 2021
Estimated Completion Date:
March 30, 2023

Study 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.

Connect with a study center

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 0931730000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 0371450003
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 0371450008
    China

    Active - Recruiting

  • Qinghai University Affiliated Hospita

    Xining, Qinghai 0971810001
    China

    Active - Recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi 029710068
    China

    Active - Recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang 0991830001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang 0991830054
    China

    Active - Recruiting

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