Hellenic Registry for cIAIs (HERCO-II)

Completed

• Conditions: Intra-abdominal Infection

• Registration Number: NCT05549076
• Lead Sponsor: Maximos Frountzas

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)

Study Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-17
• Study First Posted: 2022-09-22
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Status Verified: 2023-12
• Study Completion: 2023-12-25
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morbidity	30 days	Overall complications due to complicated intra-abdominal infections

Secondary Outcome Measures

Name	Time	Method
Multidrug resistant pathogen cultures	30 days	Results of pathogen cultures indicating multi-drug resistant variants.
Length of stay	30 days	Days of hospitalization
Length of ICU stay	30 days	Days in the ICU
Organ failure	30 days	Dysfunction of one ore more organs
Re-operation rate	30 days	Re-operations after first surgical procedure
Mortality	30 days	Number of deaths due to complicated intra-abdominal infections

Trial Locations

Locations (1)

Hippocration General Hospital; 🇬🇷 Athens, Greece