PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment

NCT06319677 | Not Yet Recruiting

• 1 other identifier: Ivljingjing
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients.

Conditions

Critical Illness; Extracorporeal Membrane Oxygenation Complication

Keywords

Critical Illness; ECMO; Population Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Blood drug concentration

  Plasma drug concentration

  Samples were taken in the first 72 hours after administration according to the sampling schedule

• Pharmacokinetic parameter

  Area under the plasma concentration-time curve（AUC）

  24 hours after administration

• Pharmacokinetic parameter

  Peak Plasma Concentration (Cmax)

  12 hours after administration

Secondary Outcomes (1)

• Mortality at 14 and 28 days

  Day 30 of the patient's admission

Study Arms (2)

ECMO treatment group

Critically ill adult patients treated with ECMO using one or more antimicrobial agents

Device: ECMO treatment

Non-ECMO treatment group

Critically ill adult patients using one or more antimicrobial agents not receving ECMO

Interventions

ECMO treatment DEVICE

Critically ill patients were treated with ECMO while receiving antimicrobial therapy

ECMO treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients using one or more antimicrobial agents receiving or not receiving ECMO

You may qualify if:

• Written informed consent was obtained from the patient or family member
• Patients who are undergoing ECMO or not
• Anti-infection treatment indications

You may not qualify if:

• Patients under 18 years of age or pregnant
• Information on antimicrobial therapy and ECMO support is incomplete
• Presence of other circumstances that make participation in this study inappropriate

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Third Hospital, Central South University

Changsha, Hunan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected before and after dosing according to sampling protocol.Each sample will be about 1-2 mL, for a total of about 12 mL.

MeSH Terms

Conditions

Critical Illness

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Jingjing Liu

  Xiangya Third Hospital, Central South University

  STUDY CHAIR

Central Study Contacts

Jingjing Liu, Doctor

CONTACT

+86 0731-88618170; ivljingjing@126.com

Shengnan Zhang

CONTACT

+86 18084668240; secnanzhang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: March 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 20, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)