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Prolonged infusion time and colistin side effects

Evaluating the effect of prolonging the infusion time on the pharmacokinetic profile, and adverse effects of Colistin

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160713028901N6
Enrollment
30
Registered
2024-04-10
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Acute kidney injury. Acute kidney failure

Interventions

Intervention 1: Intervention group: For people in the intervention group, Cleistin will be administered as a long-term infusion (2 hours). Intervention 2: Control group: The control group will receive

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 18 years Receiving colistin with the appropriate dose of renal function, every 8 hours eGFR above 50 No history of acute kidney injury (based on medical history)

Exclusion criteria

Exclusion criteria: Recent use of colistin in the past 7 days Use of colistin for less than 3 days Simultaneous reception of other nephrotoxic drugs such as vancomycin, aminoglycosides, amphotericin B

Design outcomes

Primary

MeasureTime frame
Serum colistin concentration. Timepoint: We will collect 4 blood samples each from both the control group and the intervention group in order to obtain the AUC of colistin, in this way, we will take the first sample 15 minutes after the end of the colistin infusion to determine the peak of the drug and the fourth sample It should be taken 30 minutes before we want to inject the next infusion in order to determine the drug profile, and we take two more samples in the time between the first and fourth samples. The first sample we take should be after the fifth dose so that the level of colistin concentration in the blood has reached a steady state. Method of measurement: We take 3cc samples in heparin tubes and centrifuge them to separate their plasma; We keep the separated plasma in the freezer at -80°C to analyze and check the samples with the help of HPLC to obtain the colistin serum concentration in each step; This measurement will be done as a service purchase from one of Tehran's research laboratories.;Acute kidney injury. Timepoint: Immediately after receiving the first dose of colistin, and 48 hours after starting colistin. Method of measurement: Acute kidney injury will be defined according to the KDIGO criteria: an increase in serum creatinine greater than or equal to 0.3 mg/dL within 48 hours, or an increase in serum creatinine greater than or equal to 1.5 times the baseline level, or a urine volume of less than 0.5 mL/min. kg per hour for 6 hours.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShirinsadat Badri

Esfahan University of Medical Sciences

badri@pharm.mui.ac.ir+98 31 3792 7068

Outcome results

None listed

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