Clinical trial NCT05549076: Hellenic Registry for cIAIs (HERCO-II)
Official title: Complicated Intra-abdominal Infections - the Greek Reality: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-abdominal Infection
Keywords: complicated
intra-abdominal
infection
greek
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complicated intra-abdominal infections.

Brief 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)

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Signed consent from patient or authorized representative
3. Complicated Intra-Abdominal Infection

   * Acute appendicitis with localized or diffuse peritonitis
   * Grade II or Grade III acute cholecystitis (Tokyo guidelines)
   * Visceral organ perforation with peritonitis
   * Bowel perforation after colonoscopy
   * Complicated diverticulitis (WSES classification)
   * Anastomotic leaks with abscess, localized or diffuse peritonitis

Exclusion Criteria:

1. Age \< 18 years old
2. No signed consent from patient or authorized representative

Primary outcomes:
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Length of ICU stay
timeFrame: 30 days
measure: Organ failure
timeFrame: 30 days
measure: Re-operation rate
timeFrame: 30 days
measure: Multidrug resistant pathogen cultures
timeFrame: 30 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration General Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Konstantinos G Toutouzas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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