Sodium Bicarbonate Ringer's Solution for Preventing and Treating Hyperlactacidemia During Hepatectomy
NCT ID: NCT04547296
Last Updated: 2021-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
484 participants
INTERVENTIONAL
2021-04-28
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BRS group
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.
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.
ARS group
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Henan Provincial People's Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
LanZhou University
OTHER
Affiliated Hospital of Qinghai University
OTHER
Shaanxi Provincial People's Hospital
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Qiang Wang, PHD
Role: STUDY_CHAIR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Qinghai University Affiliated Hospita
Xining, Qinghai, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Countries
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Central Contacts
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Facility Contacts
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Yatao Liu, MD
Role: primary
Xihua Lu, MD
Role: primary
jiaqiang zhang, PHD
Role: primary
Zhen Jia, MD
Role: primary
Rui Yang, MD
Role: primary
Guiping Xu, PHD
Role: primary
Yi Hong, PHD
Role: primary
Other Identifiers
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XJTU1AF2020LSK-071
Identifier Type: -
Identifier Source: org_study_id
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