An interventional study of Sodium Bicarbonate Ringer's Solution in Hyperlactacidemia, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 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.
Also known as: Acetate Ringer's Solution
Incidence of intraoperative hyperlactacidemia
Diagnostic criteria: Lac ≥ 2 mmol/L, pH ≤ 7.35, HCO3- ≤ 20 mmol/L, PaCO2 \<50 mmHg
Time frame: During the operation
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
Time frame: During the operation
Incidence of postoperative acute kidney injury
The incidence of acute kidney injury within 48h after surgery was recorded
Time frame: Day 2 after the operation
Rate of postoperative complications
postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications
Time frame: Day 30 after the operation
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University