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Effect of different perioperative prophylaxis with antibiotics in pediatric cardiac surgery on the incidence of infectious complications

Effect of different perioperative prophylaxis with antibiotics in pediatric cardiac surgery on the incidence of infectious complications - EffDiffPeriopABPedCardSurgInfCompl

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004445
Enrollment
150
Registered
2013-08-19
Start date
2012-10-09
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Pediatric patients with congenital heart desease (CHD) and the need for surgical correction, e. g. atrial septal defect (Q 21.1) but also every other CHD. Q21.1

Interventions

Group 1: Postoperative application of Cefotaxime for prophylaxis, duration of application 5 days (= 15 postoperative doses): weight adapted dosage, 100 mg/kg/d iv divided by 3 doses, maximum daily dos

Sponsors

Universitätsklinikum des Saarlandes
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: - Pediatric patients up to the age of 18 years with congenital heart disease and with the need of surgical intervention - Written consent of the parents/persons who have the care and custody of the children and, depending on the age, of the patients capable of insight, all children and adolescents aged 0 to 18 years

Exclusion criteria

Exclusion criteria: - Absent of written consent - Known allergic reactions or incompatibility of the planned antibiotics - Indication for delayed sternal closure - Known colonisation with multi-drug resistant bacteria - Antibiotic treatment within the last 7 days preoperatively

Design outcomes

Primary

MeasureTime frame
Appearance of wound infections and other infections: - clinical assessment preoperatively, on admission to ICU and in the course of time in hospital - blood work preoperatively, on admission to ICU and day one and three postoperatively (e. g. CrP, Procalitonin, WBC)

Secondary

MeasureTime frame
- Positive culture from foreign bodies, i. e. CVL, thoracic drainage, tube, pacing wires - Duration of ventilation - Stay in ICU - Stay in hospital - CrP and Procalzitonin - Endocarditis up to 6 months postoperatively

Countries

Germany

Contacts

Public ContactHarald Sauer

Universitätsklinikum des Saarlandes Klinik für Pädiatrische Kardiologie

harald.sauer@uks.eu06841 - 16 28374

Outcome results

None listed

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