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Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in children

Evaluation of the effect of adding long subcutaneous insulin to the standard treatment of diabetic ketoacidosis in children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201125049485N1
Enrollment
108
Registered
2021-01-05
Start date
2020-11-11
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

acute phase of diabetic ketoacidosis. Endocrine, nutritional and metabolic diseases.

Interventions

Intervention 1: Intervention group 1: Children who in the first 6 hours of treatment, in addition to receiving short-term standard insulin drip, receive a long dose of subcutaneous insulin effect of D

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: age between 2 to 15 years old acute diabetic ketoacidosis : BS> 200 mg / dL, PH <7.30 , HCO3 <15 mEq / L ,urinary ketone positive

Exclusion criteria

Exclusion criteria: • Reluctance to participate in the study

Design outcomes

Primary

MeasureTime frame
Duration of exit from the acute phase of diabetic ketoacidosis.Exclusion from the acute phase in this study is a condition in which the serum level is PH> 7.30, HCO3> 15mEq / L, normal serum electrolytes, the patient is conscious and does not vomit. Timepoint: From the time of diagnosis of diabetic ketoacidosis to the time of exit from the acute phase. Method of measurement: Time to hour.

Secondary

MeasureTime frame
Determining the average length of hospital stay in the PICU. Timepoint: From the beginning of hospitalization to the time of leaving the PICU. Method of measurement: Time to hour.;Evaluation of side effect from drug use during the study period: Hypoglycemia. Timepoint: From the beginning of the acute phase of diabetic ketoacidosis until the exit of the acute phase. Method of measurement: Frequent laboratory and glucotest monitoring of blood plasma.;Evaluation of side effects due to drug use during the study period: Hypokalemia. Timepoint: From the beginning of the acute phase of diabetic ketoacidosis until the exit of the acute phase. Method of measurement: Laboratory measurement of plasma potassium levels every three hours.;Cerebral edema. Timepoint: From starting treatment for diabetic ketoacidosis to having criteria for exiting the acute phase. Method of measurement: Have any signs or symptoms of high intracranial pressure on clinical examination and vital signs according to international standards.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVictoria Chegini

Qazvin University of Medical Sciences

victoria_che@yahoo.com+98 28 3333 4807

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026