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PK/PD study for high-dose tigecycline in patients with sepsis and hypoproteinemia

PK/PD study for high-dose tigecycline in patients with sepsis and hypoproteinemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018567
Enrollment
Unknown
Registered
2018-09-25
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-12-10

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

Conditions

hypoproteinemia

Interventions

Sponsors

Changxing People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) aged 18 years, male or female used high-dose tigecycline 100 mg or more per day; (2) Meet the sepsis diagnose standard of The Third International Consensus Definitions for Sepsis and Septic Shock ( Sepsis-3); (3) The presence of hypoproteinemia during the course of administration, ie serum albumin <25 g/L.

Exclusion criteria

Exclusion criteria: (1) patients who are allergic to or have a history of allergies to tetracyclines; (2) patients who refuse to participate the study, or who are unable to obtain blood samples due to unwillingness of the patient and the family of the patient; (3) unacceptable adverse reactions or Serious adverse events; (4) pregnant women; (5) patients with hypoproteinemia who were corrected before tigecycline.

Design outcomes

Primary

MeasureTime frame
Peak concentration;Trough concentrations;albumin;

Secondary

MeasureTime frame
age;sexual;weight;APACHE II score;Hospital stay time;clinical diagnosis;The site of infection;Procalcitonin;body temperature;leukocyte;C-reactive protein;

Countries

China

Contacts

Public ContactLin Bin

Changxing People's Hospital

lb_wzmc@126.com+86 13967299420

Outcome results

None listed

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