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Nebulized Salbutamol Facilitate Management of Hyperkalemia Postreperfusion During Liver Transplantation

Plain-language guide to NCT05589441: not phased randomized trial of Insulin (regular human), 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05589441
Phase
not phased
Status
status unknown
Start
2022-10-28
Completion (planned or actual)
2023-10-10
Participants
100 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Liver Transplantation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Insulin (regular human).

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.

It had two arms (groups): Nebulized inhalation of salbutamol group (experimental) and Insulin complex glucose group (experimental).

The registry classes the interventions as drug.

More on the Plan

Severe hyperkalemia can be life-threatening in the form of abnormalities.

Hyperkalemia is a common complication in orthotopic liver transplantation.

Especially in patients with renal insufficiency, the clinical manifestations are more dangerous, which can lead to serious complications.

Arrhythmias and even cardiac arrest.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 20 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients aged 20 to 70 years old;. Cardiac function grades I to III (NYHA standard);. Plan to undergo orthotopic liver transplantation;. Those who are willing to sign the informed consent form.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: intraoperative crrt patients;; those who are allergic to the test drug;; refuse to join the trial investigator;.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-10-28 with completion listed for 2023-10-10.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Blood potassium concentration,mmol/L (time frame: measured blood gas at 5 minutes before treatment). Blood potassium concentration,mmol/L (time frame: measured blood gas at 5 minutes after treatment). Blood potassium concentration,mmol/L (time frame: measured blood gas at 10 minutes after treatment).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.