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InSaKa trial: Insulin dextrose infusion versus nebulized salbutamol versus combination of salbutamol and insulin dextrose in acute hyperkalemia: a randomized clinical trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514889-40-00
Acronym
RC19_0048
Enrollment
525
Registered
2024-07-19
Start date
2019-12-20
Completion date
2025-12-20
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperkalemia

Brief summary

Mean change in the absolute serum potassium level from baseline to 60 minutes (measured in mmol/l)

Detailed description

Mean change in the serum potassium level from baseline to 180 minutes and 24 hours, Proportion of patients who had a serum potassium level of 4 mmol/l to less than 4.9 mmol/l at 60, 180 minutes and 24 hours, Proportion of patients who require re-treatment or dialysis at 60, 180 minutes and 24 hours, Proportion of patients with adverse effects at 60 and 180 minutes, Proportion of patients with heart rhythm disorders or high grade atrioventricular bloc that required urgent medication during the first 180 minutes, Proportion of patients with electrocardiographic abnormalities, at 60, 180 minutes and 24 hours, Proportion of major cardiovascular events at 60, 180 minutes and 24 hours

Interventions

DRUGGLUCOSE
DRUGSALBUTAMOL ARROW 5 mg/2
DRUG5 ml
DRUGsolution pour inhalation par nébuliseur en récipient unidose
DRUGSALBUTAMOL VIATRIS 5 mg/2
DRUGsolution pour inhalation par nébuliseur en récipient unidose

Sponsors

Centre Hospitalier Universitaire De Nantes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change in the absolute serum potassium level from baseline to 60 minutes (measured in mmol/l)

Secondary

MeasureTime frame
Mean change in the serum potassium level from baseline to 180 minutes and 24 hours, Proportion of patients who had a serum potassium level of 4 mmol/l to less than 4.9 mmol/l at 60, 180 minutes and 24 hours, Proportion of patients who require re-treatment or dialysis at 60, 180 minutes and 24 hours, Proportion of patients with adverse effects at 60 and 180 minutes, Proportion of patients with heart rhythm disorders or high grade atrioventricular bloc that required urgent medication during the first 180 minutes, Proportion of patients with electrocardiographic abnormalities, at 60, 180 minutes and 24 hours, Proportion of major cardiovascular events at 60, 180 minutes and 24 hours

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026