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Trials / Completed

CompletedNCT05549076

Hellenic Registry for cIAIs (HERCO-II)

Complicated Intra-abdominal Infections - the Greek Reality: a Prospective Observational Study

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
Maximos Frountzas · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers

Summary

Complicated Intra-Abdominal Infections (cIAIs) represent an emergent surgical situation which lead to important non trauma-related mortality in several Emergency Surgical Centers worldwide. Their prevalence seemed to be unrelated to age, gender, health status and socioeconomic condition. Early diagnosis, timely septic source control, wide-spectrum antibiotic delivery and resuscitation with fluids and vasoactive agents in critically ill patients are fundamentals for successful cIAIs management. Moreover, septic shock, antibiotic resistant multi-pathogens and comorbidities have been associated with increased morbidity and mortality of cIAIs. Several international health associations announce updated guidelines for cIAIs management. Nevertheless, such guidelines could not be widely implemented, because of specific features of several healthcare systems worldwide. The aim of the present study is to investigate the prevalence of cIAIs among the Greek health system and the potential association of time interval of septic source control, preoperative resuscitation and multidrug resistant pathogens with morbidity, mortality, ICU stay and length of stay in patients with cIAIs.

Detailed description

Registry of patients with complicated intra-abdominal infections including: * Patient demographics (gender, age, Carlson Comorbidity Index, cancer history/chemotherapy during the last 6 months, health unit stay during the last 6 months) * Management (conservative, minimally invasive, surgical) * Minimally invasive procedure - type (CT-guided drainage, endoscopic) * Surgical procedure - type (open or laparoscopic, day or night, procedure description) * Cultures (blood, peritoneal fluid, tissue) * Time of diagnosis (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, white cell count, CRP) * Just before procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, vasoactive agent delivery, intubation) * Intraoperative parameters (time interval between diagnosis and intervention, WSES score, operative time, open abdomen, VAC) * After procedure (respiratory rate, heart rate, systolic blood pressure, lactate acid in blood gases, temperature, vasoactive agent delivery, intubation) * Empirical wide-spectrum antibiotics (type and time interval from diagnosis)

Conditions

Timeline

Start date
2022-10-01
Primary completion
2023-10-01
Completion
2023-12-25
First posted
2022-09-22
Last updated
2023-12-28

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT05549076. Inclusion in this directory is not an endorsement.