Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation

NCT05589441 | Unknown

• 1 other identifier: XJTU1AF-CRF-2019-021
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The therapeutic effect of nebulized salbutamol on hyperkalemia during reperfusion in liver transplantation patients. Secondary research objectives: To observe the results of blood gas analysis, changes in urinary potassium and hemodynamic parameters, and the incidence of reperfusion syndrome in liver transplantation, and to observe the incidence of postoperative pulmonary complications during the 7-day follow-up. To explore the effect of aerosol inhalation of salbutamol on new liver reperfusion syndrome in patients with liver transplantation, and to provide a theoretical basis for clinical treatment.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (10)

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 5 minutes before treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 5 minutes after treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 10 minutes after treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 15 minutes after treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 30 minutes after treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 45 minutes after treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 60 minutes after treatment

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 30 seconds after reperfusion

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 5 minutes after reperfusion

• Blood potassium concentration,mmol/L

  Patients who met the inclusion and exclusion criteria were enrolled and assigned random numbers. After randomization, the intervention was given at the beginning of the anhepatic phase according to the grouping

  measured blood gas at 30 minutes after reperfusion

Study Arms (2)

Nebulized inhalation of salbutamol group

EXPERIMENTAL

10 mg salbutamol diluted to 2 ml with distilled water and inhaled as aerosolized for 15 min before the start of the hepatic-free phase.

Drug: salbutamol

Insulin complex glucose group

EXPERIMENTAL

Intravenous injection of 8U of insulin complex 10% glucose solution 250 ml before the start of the hepatic phase was completed in 15 minutes.

Drug: Insulin

Interventions

salbutamol DRUG

10 mg salbutamol diluted to 2 ml with distilled water and inhaled as aerosolized for 15 min before the start of the hepatic-free phase.

Also known as: Nebulized inhalation of salbutamol

Nebulized inhalation of salbutamol group

Insulin DRUG

Intravenous injection of 8U of insulin complex 10% glucose solution 250 ml before the start of the hepatic phase was completed in 15 minutes.

Also known as: Insulin complex glucose group

Insulin complex glucose group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 to 70 years old;
• Cardiac function grades I to III (NYHA standard);
• Plan to undergo orthotopic liver transplantation;
• Serum potassium ion concentration greater than 4 mmol/h at the beginning of anhepatic phase;
• Those who are willing to sign the informed consent form.

You may not qualify if:

• Intraoperative CRRT patients;
• Those who are allergic to the test drug;
• refuse to join the trial investigator;
• Patients who are participating in other clinical trials, the researchers believe that other reasons are not suitable for clinical trials.
• Anyone with any of the above conditions cannot be selected for this trial.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Related Publications (1)

• Ding Y, Wen J, Xiao Y. Comparison of nebulized salbutamol and glucose-insulin for preventing acute hyperkalemia in liver transplantation: a randomized, double-blind trial. J Anesth. 2026 Jan 21. doi: 10.1007/s00540-025-03643-2. Online ahead of print.

  PMID: 41565838 DERIVED

MeSH Terms

Interventions

Albuterol; Insulin

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jian Wen, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Wang, PhD

CONTACT

18049286968; dr.wangqiang@139.com

Jian Wen, PhD

CONTACT

18792520896; Wenjian1997@126.com

Study Design

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

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: October 21, 2022
• Study Start: October 28, 2022
• Primary Completion: October 10, 2023
• Study Completion: January 10, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share