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Completed

NCT Number: NCT05549076

Hellenic Registry for cIAIs (HERCO-II)

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hippocration General Hospital

Athens, Greece

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Signed consent from patient or authorized representative
  • 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

  • Age < 18 years old
  • No signed consent from patient or authorized representative

Treatment and study plan

Primary outcomes

  1. Morbidity

    Time frame: 30 days

    Overall complications due to complicated intra-abdominal infections

Secondary outcomes

  1. Mortality

    Time frame: 30 days

    Number of deaths due to complicated intra-abdominal infections

  2. Length of stay

    Time frame: 30 days

    Days of hospitalization

  3. Length of ICU stay

    Time frame: 30 days

    Days in the ICU

  4. Organ failure

    Time frame: 30 days

    Dysfunction of one ore more organs

  5. Re-operation rate

    Time frame: 30 days

    Re-operations after first surgical procedure

  6. Multidrug resistant pathogen cultures

    Time frame: 30 days

    Results of pathogen cultures indicating multi-drug resistant variants.

Sponsors and collaborators

Lead sponsor

Maximos Frountzas

Other

Registry information

Official study title

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

Acronym: HERCO-II

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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