Hyperlactacidemia Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 484 |
| Est. completion date | March 30, 2023 |
| Est. primary completion date | October 9, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
| China | People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang |
| China | The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang |
| China | Shaanxi Provincial People's Hospital | Xi'an | Shaanxi |
| China | Qinghai University Affiliated Hospita | Xining | Qinghai |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| China | Henan Provincial People's Hospital | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | Affiliated Hospital of Qinghai University, First Affiliated Hospital of Xinjiang Medical University, Henan Cancer Hospital, Henan Provincial People's Hospital, LanZhou University, People's Hospital of Xinjiang Uygur Autonomous Region, Shaanxi Provincial People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of intraoperative hyperlactacidemia | Diagnostic criteria: Lac = 2 mmol/L, pH = 7.35, HCO3- = 20 mmol/L, PaCO2 <50 mmHg | During the operation | |
| Secondary | 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 | |
| Secondary | Incidence of postoperative acute kidney injury | The incidence of acute kidney injury within 48h after surgery was recorded | Day 2 after the operation | |
| Secondary | Rate of postoperative complications | postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications | Day 30 after the operation |