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Clinical impact of pharmacokinetic monitoring of antibiotics in critically ill patients

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504480-17-00
Acronym
IIBSP-TDM-2023-28
Enrollment
384
Registered
2023-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

Critical Patients admitted to the ICU

Brief summary

- Days of admission to ICU - Days of hospital admission - Days on mechanical ventilation - Days on vasoactive drug treatment - Fever - Biomarkers: procalcitonin and C-reactive protein - SOFA scale. Includes Glasgow scale, oxygen saturation, FIO2, mean arterial pressure, dobutamine use, dopamine dose, noradrenaline dose, daily diuresis (measured on days 1, 3, 7 and end of treatment) - Mortality at 30 days.

Detailed description

Sociodemographics: age, sex, weight, height, medical service (intensive care, coronary unit, anaesthesia)., Initial clinical data: Charlson index, 10-year survival according to Charlson, presence of relevant comorbidities (diabetes mellitus, heart failure, chronic obstructive pulmonary disease, chronic renal failure, active neoplasia, chronic treatment with corticosteroids, immunosuppressants or chemotherapy, solid organ or haematopoietic progenitor transplant recipients, liver cirrhosis), APACHEII, SAPSII, reason for admission........., Treatment data: antibiotic administered (duration of treatment, dosing regimen, dose and time of administration), date and time of antibiotic initiation, antibiotic used previously (only up to the previous day), concomitant anti-infectives used., Other analytical variables (day of start of treatment, day 3 and day 7 of treatment and end of treatment): urea, creatinine, bilirubin, aspartate transaminase (AST) and alanine transaminase (ALT) enzymes, alkaline phosphatase (ALP), gamma glutamyl transpeptidase (GGT), creatinine kinase (CK), albumin, haemoglobin, haematocrit, platelets, leukocytes, neutrophils, activated partial thromboplastin time (aPTT) and volume, collection time and urine creatinine if performed during treatment., Other clinical data during follow-up: positive cultures (sample, microorganism, sensitivity and MIC if tested), Clostridium difficile toxin detection, water balance, ECMO, ventricular assist or renal replacement therapy (RRT) including duration, type and modality and regimen in case of continuous RRT., Intervention data: number of interventions, date and time of intervention, dosing regimen and administration time after intervention, estimated pharmacokinetic parameters (minimum or trough concentration, maximum or peak concentration, area under the 24-hour curve, volume of distribution, half-life).

Interventions

DRUGDAPTOMYCIN
DRUGMEROPENEM
DRUGCEFEPIME
DRUGLINEZOLID

Sponsors

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- Days of admission to ICU - Days of hospital admission - Days on mechanical ventilation - Days on vasoactive drug treatment - Fever - Biomarkers: procalcitonin and C-reactive protein - SOFA scale. Includes Glasgow scale, oxygen saturation, FIO2, mean arterial pressure, dobutamine use, dopamine dose, noradrenaline dose, daily diuresis (measured on days 1, 3, 7 and end of treatment) - Mortality at 30 days.

Secondary

MeasureTime frame
Sociodemographics: age, sex, weight, height, medical service (intensive care, coronary unit, anaesthesia)., Initial clinical data: Charlson index, 10-year survival according to Charlson, presence of relevant comorbidities (diabetes mellitus, heart failure, chronic obstructive pulmonary disease, chronic renal failure, active neoplasia, chronic treatment with corticosteroids, immunosuppressants or chemotherapy, solid organ or haematopoietic progenitor transplant recipients, liver cirrhosis), APACHEII, SAPSII, reason for admission........., Treatment data: antibiotic administered (duration of treatment, dosing regimen, dose and time of administration), date and time of antibiotic initiation, antibiotic used previously (only up to the previous day), concomitant anti-infectives used., Other analytical variables (day of start of treatment, day 3 and day 7 of treatment and end of treatment): urea, creatinine, bilirubin, aspartate transaminase (AST) and alanine transaminase (ALT) enzymes, alka

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026