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

NCT04547296 | Unknown DMC

• 1 other identifier: XJTU1AF2020LSK-071
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Hyperlactacidemia

Keywords

hyperlactacidemia; Sodium bicarbonate Ringer's solution; Acetate Ringer's solution; hepatectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative hyperlactacidemia

  Diagnostic criteria: Lac ≥ 2 mmol/L, pH ≤ 7.35, HCO3- ≤ 20 mmol/L, PaCO2 \<50 mmHg

  During the operation

Secondary Outcomes (3)

• The incidence of blood gas index disorder

  During the operation

• Incidence of postoperative acute kidney injury

  Day 2 after the operation

• Rate of postoperative complications

  Day 30 after the operation

Study Arms (2)

BRS group

EXPERIMENTAL

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

ARS group

EXPERIMENTAL

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

Interventions

Sodium Bicarbonate Ringer's Solution DRUG

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

ARS group; BRS group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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%.
• 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.
• 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).
• Patients with a history of hypothyroidism; pregnant or lactating women.
• Patients with a history of adverse blood transfusion reactions; those who refuse blood transfusions.
• Participation in other clinical studies within 3 months before admission to this study.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Henan Provincial People's Hospital: collaborator
• Henan Cancer Hospital: collaborator
• LanZhou University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator

Study Sites (7)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 0931730000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 0371450003, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 0371450008, China

RECRUITING

Qinghai University Affiliated Hospita

Xining, Qinghai, 0971810001, China

RECRUITING

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 029710068, China

RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 0991830001, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 0991830054, China

RECRUITING

MeSH Terms

Conditions

Hyperlactatemia

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiang Wang, PHD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Wei Gao, PHD

CONTACT

0086-15209225834; gaowei2906@xjtufh.edu.cn

Qiang Wang, PHD

CONTACT

0086-18049286968; dr.wangqiang@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 14, 2020
• Study Start: April 28, 2021
• Primary Completion: October 9, 2022
• Study Completion: March 30, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (7)