Renal complications of Amikacin in patients with neonatal sepsis

Study of the difference of renal complications in single and double daily dose of Amikacin in patients with neonatal sepsis in Imam Khomeini Hospital in Tehran: A double blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201212049686N1

Enrollment

Registered

2021-01-18

Start date

2019-06-05

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

neonatal Sepsis. Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

Interventions

Intervention 1: Intervention group: the first group received 15 mg/kg Amikacin once daily. Intravenous administration of amikacin made by Caspian Iran Company was performed for 7 days. Intervention 2:

Eligibility

Sex/Gender

All

Age

3 Days to 1 Months

Inclusion criteria

Inclusion criteria: patients with neonatal sepsis Parental consent to participate in the study

Exclusion criteria

Exclusion criteria: incomplete treatment parental dissatisfaction with continuing treatment evidence of asphyxia renal abnormalities at birth

Design outcomes

Primary

Measure	Time frame
GFR above 30%. Timepoint: Before and after seven days of treatment. Method of measurement: First, serum creatinine level was measured and GFR was calculated using the Schwartz formula: Creatinine clearance in millimeters per minute per 1/73 square meter of body surface =height in cm * K/ serum creatinine (in this formula: K in premature infants up to one year of age 0.33%, in infants Semester up to one year is 0.45%).	—

Measure

Time frame

GFR above 30%. Timepoint: Before and after seven days of treatment. Method of measurement: First, serum creatinine level was measured and GFR was calculated using the Schwartz formula: Creatinine clearance in millimeters per minute per 1/73 square meter of body surface =height in cm * K/ serum creatinine (in this formula: K in premature infants up to one year of age 0.33%, in infants Semester up to one year is 0.45%).

—

Secondary

Measure	Time frame
Creatinine clearance. Timepoint: before one one week after Amikacin administration. Method of measurement: First, serum and urine creatinine were calculated and the creatinine clearance was calculated using the following formula: Urine creatinine * Urine volume / Serum creatinine.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Fazel

Tehran University of Medical Sciences

mojtabafazel@yahoo.com+98 21 6119 2240

Outcome results

None listed

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