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

Primary Purpose

Hyperlactacidemia

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sodium Bicarbonate Ringer's Solution

About this trial

This is an interventional treatment trial for Hyperlactacidemia focused on measuring hyperlactacidemia, Sodium bicarbonate Ringer's solution, Acetate Ringer's solution, hepatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
The investigator considers it unsuitable for inclusion.

Sites / Locations

The First Hospital of Lanzhou UniversityRecruiting
Henan Cancer HospitalRecruiting
Henan Provincial People's HospitalRecruiting
Qinghai University Affiliated HospitaRecruiting
Shaanxi Provincial People's HospitalRecruiting
People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BRS group

ARS group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of intraoperative hyperlactacidemia

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

Secondary Outcome Measures

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

Incidence of postoperative acute kidney injury

The incidence of acute kidney injury within 48h after surgery was recorded

Rate of postoperative complications

postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications

Full Information

NCT ID

NCT04547296

First Posted

August 25, 2020

Last Updated

August 17, 2021

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Henan Provincial People's Hospital, Henan Cancer Hospital, LanZhou University, Affiliated Hospital of Qinghai University, Shaanxi Provincial People's Hospital, First Affiliated Hospital of Xinjiang Medical University, People's Hospital of Xinjiang Uygur Autonomous Region

1. Study Identification

Unique Protocol Identification Number

NCT04547296

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 28, 2021 (Actual)

Primary Completion Date

October 9, 2022 (Anticipated)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlactacidemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

484 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BRS group

Arm Type

Experimental

Arm Description

Arm Title

ARS group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Sodium Bicarbonate Ringer's Solution

Other Intervention Name(s)

Acetate Ringer's Solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of intraoperative hyperlactacidemia

Description

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

Time Frame

During the operation

Secondary Outcome Measure Information:

Title

The incidence of blood gas index disorder

Description

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

Title

Incidence of postoperative acute kidney injury

Description

The incidence of acute kidney injury within 48h after surgery was recorded

Time Frame

Day 2 after the operation

Title

Rate of postoperative complications

Description

postoperative complications: cardiovascular complications; pulmonary complications; infection complications; other complications

Time Frame

Day 30 after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. The investigator considers it unsuitable for inclusion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Gao, PHD

Phone

0086-15209225834

gaowei2906@xjtufh.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Qiang Wang, PHD

Phone

0086-18049286968

dr.wangqiang@139.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiang Wang, PHD

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Study Chair

Facility Information:

Facility Name

The First Hospital of Lanzhou University

City

Lanzhou

State/Province

Gansu

ZIP/Postal Code

0931730000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yatao Liu, MD

Phone

0086-18152107860

First Name & Middle Initial & Last Name & Degree

Yatao Liu, MD

Facility Name

Henan Cancer Hospital

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

0371450003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xihua Lu, MD

Phone

0086-18539965618

First Name & Middle Initial & Last Name & Degree

Xihua Lu, MD

Facility Name

Henan Provincial People's Hospital

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

0371450008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jiaqiang zhang, PHD

Phone

0086-13937121360

First Name & Middle Initial & Last Name & Degree

jiaqiang zhang, PHD

Facility Name

Qinghai University Affiliated Hospita

City

Xining

State/Province

Qinghai

ZIP/Postal Code

0971810001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhen Jia, MD

Phone

0086-13519702706

First Name & Middle Initial & Last Name & Degree

Zhen Jia, MD

Facility Name

Shaanxi Provincial People's Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

029710068

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui Yang, MD

Phone

0086-13572135219

First Name & Middle Initial & Last Name & Degree

Rui Yang, MD

Facility Name

People's Hospital of Xinjiang Uygur Autonomous Region

City

Ürümqi

State/Province

Xinjiang

ZIP/Postal Code

0991830001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guiping Xu, PHD

Phone

0086-13669988366

First Name & Middle Initial & Last Name & Degree

Guiping Xu, PHD

Facility Name

The First Affiliated Hospital of Xinjiang Medical University

City

Ürümqi

State/Province

Xinjiang

ZIP/Postal Code

0991830054

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Hong, PHD

Phone

0086-13009620188

First Name & Middle Initial & Last Name & Degree

Yi Hong, PHD

12. IPD Sharing Statement

Learn more about this trial

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

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