Trial · NCT05443802
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Metabolic complications | 48 hours | Proportion of patients with metabolic complications (hypokalaemia \<3.5 mmol/L and/or hypoglycemia \<3.9 mmol/L) treated with a reduced dose of insulin (0.05 IU/kg/h) compared with the control group receiving the 0.10 IU/kg/h dose. |
| Secondary | Resolution of diabetic ketoacidosis | 48 hours | Time in hours between randomisation and resolution of diabetic ketoacidosis (defined by ph\>7.3 and ketonemia \< 3 mmol/L and bicarbonates\> 15 mmol/L) |
| Secondary | Episode of hypokalaemia | 48 hours | Proportion of patients with at least one episode of hypokalaemia \< 3.5 mmol/L between randomization and resolution of DKA |
| Secondary | Episode of hypoglycemia | 48 hours | Proportion of patients with at least one episode of hypoglycemia \< 3.9 mmol/L between randomization and resolution of DKA |
| Secondary | Episode of severe hypoglycemia | 48 hours | Proportion of patients with at least one episode of hypoglycemia \< 2.9 mmol/L between randomization and resolution of DKA |
| Secondary | Cardiac arrythmia diagnosed by EKG | 48 hours | Proportion of patients with onset of new cardiac arrhythmia diagnosed by EKG analysis (atrial fibrillation and ventricular arrhythmia) and scopic monitoring between randomization and resolution of DKA |
| Secondary | Glucose infusion 1000mL | 48 hours | Proportion of patients who received more than 1000 mL of 10% glucose solution (indicating tendency of hypoglycemia) between randomization and resolution of DKA or 48h after inclusion if DKA is unresolved |
| Secondary | Glucose infusion of 30% glucose solution | 48 hours | Proportion of patients who received one perfusion of 30% glucose solution between randomization and resolution of DKA or 48h after inclusion if DKA is unresolved |
| Secondary | Amount of glucose perfused | 48 hours | Amount of glucose perfused (in grams) (glucose 5%, 10% and 30%) between randomization and resolution of the DKA or 48 hours after inclusion if the DKA is not resolved |
| Secondary | Potassium intake | 48 hours | Potassium intake (in grams) orally and intravenously between patient randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved |
| Secondary | Length of stay in ICU | 48 hours | Duration of stay (in hours) in ICU |
| Secondary | Time between patient randomization and resolution of DKA in T1D population | 48 hours | Time in hours between patient randomization and resolution of DKA in T1D population |
| Secondary | Time between patient randomization and resolution of DKA in T2D population | 48 hours | Time in hours between patient randomization and resolution of DKA in T2D population |
| Secondary | Time between patient randomization and resolution of DKA in patients suffering from first ketoacidosis episode | 48 hours | Time in hours between patient randomization and resolution of DKA in patients suffering from ketoacidosis |
| Secondary | Episode of hypokalaemia in T1D population | 48 hours | Proportion of patients with at least one episode of hypokalaemia \< 3.5 mmol/L between randomisation and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T1D population |
| Secondary | Episode of hypokalaemia in T2D population | 48 hours | Proportion of patients with at least one episode of hypokalaemia \< 3.5 mmol/L between randomisation and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T2D population |
| Secondary | Episode of hypokalaemia in patients suffering from first ketoacidosis episode | 48 hours | Proportion of patients with at least one episode of hypokalaemia \< 3.5 mmol/L between randomisation and resolution of DKA or 48 hours after inclusion if DKA is not resolved within inaugural ketoacidosis population |
| Secondary | Episode of hypoglycaemia in T1D population | 48 hours | Proportion of patients with at least one episode of hypoglycaemia \< 3.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T1D population |
| Secondary | Episode of hypoglycaemia in T2D population | 48 hours | Proportion of patients with at least one episode of hypoglycaemia \< 3.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within T2D population |
| Secondary | Episode of hypoglycaemia in patients suffering from first ketoacidosis episode | 48 hours | Proportion of patients with at least one episode of hypoglycaemia \< 3.9 mmol/L between randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved within inaugural ketoacidosis population |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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