Comparative study of the renal toxicity of dosage regimen containing high and conventional doses of colistin with monitoring of novel biomarkers of acute kidney injury

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014090614693N5

Enrollment

Registered

2014-09-23

Start date

2014-03-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: patients with hospital acquired infections due to multi drug resistant gram negative organisms. Condition 2: patients with hospital acquired infections due to multi drug resistant gram negative organisms. Condition 3: patients with hospital acquired infections due to multi drug resistant gram negative organisms. Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified to other chapters Other specified sepsis Other and unspecified infectious diseases

Interventions

Intervention 1: In high dose group, the patients receive a loading doses of 9 million units and maintenance doses of 4.5 million units colistin every 12 hours, Blood samples was drown on day 1 (before

Treatment - Drugs

In high dose group, the patients receive a loading doses of 9 million units and maintenance doses of 4.5 million units colistin every 12 hours, Blood samples was drown on day 1 (before first dose), da

In low dose group, the patients receive 2 million units colistin every 8 hours. Blood samples was drown on day 1 (before first dose), day 3, 5, 7 and 10 of treatment, serum separated and then stored a

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion: candidate for colistin therapy; at least 7 days colistin therapy; age 18-65 Exclusion: chronic kidney injury (GFR35; patient discontent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum cystatin c level. Timepoint: day 1(before first dose), 3, 5, 7, 10. Method of measurement: biochemisty kit.	—

Secondary

Measure	Time frame
Change in serum creatinin level and GFR. Timepoint: first 10 days of treatment. Method of measurement: GFR with cockroft gault equation.;Added at 2016-08-10: Neutrophil gelatinase-associated lipocalin (NGAL). Timepoint: Added at 2016-08-10: day 1, 3, 5, 7, 10. Method of measurement: Added at 2016-08-10: ELISA kit.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Atefeh Ordooei Javan

Faculty of pharmacy, Shahid Beheshti University of Medical Sciences

atefeh.ordooei.j@gmail.com+98 21 8820 0118

Outcome results

None listed

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