Hellenic Registry for cIAIs (HERCO-II) (HERCO-II)

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

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.

Study Overview

• Status: Completed
• Conditions: Intra-abdominal Infection

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Hippocration General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with complicated intra-abdominal infections.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Overall complications due to complicated intra-abdominal infections	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maximos Frountzas
• Investigators: Principal Investigator: Konstantinos G Toutouzas, MD PhD, National and Kapodistrian University of Athens

Publications and helpful links

General Publications

• Shrestha B, Dunn L. The Declaration of Helsinki on Medical Research involving Human Subjects: A Review of Seventh Revision. J Nepal Health Res Counc. 2020 Jan 21;17(4):548-552. doi: 10.33314/jnhrc.v17i4.1042.
• Ahmed S, Wilcox MH, Kirby A. Measuring outcomes in complicated intra-abdominal infections. Curr Opin Gastroenterol. 2020 Jan;36(1):1-4. doi: 10.1097/MOG.0000000000000591.
• Leone S, Damiani G, Pezone I, Kelly ME, Cascella M, Alfieri A, Pace MC, Fiore M. New antimicrobial options for the management of complicated intra-abdominal infections. Eur J Clin Microbiol Infect Dis. 2019 May;38(5):819-827. doi: 10.1007/s10096-019-03533-y. Epub 2019 Mar 23.
• Mayumi T, Okamoto K, Takada T, Strasberg SM, Solomkin JS, Schlossberg D, Pitt HA, Yoshida M, Gomi H, Miura F, Garden OJ, Kiriyama S, Yokoe M, Endo I, Asbun HJ, Iwashita Y, Hibi T, Umezawa A, Suzuki K, Itoi T, Hata J, Han HS, Hwang TL, Dervenis C, Asai K, Mori Y, Huang WS, Belli G, Mukai S, Jagannath P, Cherqui D, Kozaka K, Baron TH, de Santibanes E, Higuchi R, Wada K, Gouma DJ, Deziel DJ, Liau KH, Wakabayashi G, Padbury R, Jonas E, Supe AN, Singh H, Gabata T, Chan ACW, Lau WY, Fan ST, Chen MF, Ker CG, Yoon YS, Choi IS, Kim MH, Yoon DS, Kitano S, Inomata M, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: management bundles for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):96-100. doi: 10.1002/jhbp.519. Epub 2017 Dec 16.
• Sartelli M, Weber DG, Kluger Y, Ansaloni L, Coccolini F, Abu-Zidan F, Augustin G, Ben-Ishay O, Biffl WL, Bouliaris K, Catena R, Ceresoli M, Chiara O, Chiarugi M, Coimbra R, Cortese F, Cui Y, Damaskos D, De' Angelis GL, Delibegovic S, Demetrashvili Z, De Simone B, Di Marzo F, Di Saverio S, Duane TM, Faro MP, Fraga GP, Gkiokas G, Gomes CA, Hardcastle TC, Hecker A, Karamarkovic A, Kashuk J, Khokha V, Kirkpatrick AW, Kok KYY, Inaba K, Isik A, Labricciosa FM, Latifi R, Leppaniemi A, Litvin A, Mazuski JE, Maier RV, Marwah S, McFarlane M, Moore EE, Moore FA, Negoi I, Pagani L, Rasa K, Rubio-Perez I, Sakakushev B, Sato N, Sganga G, Siquini W, Tarasconi A, Tolonen M, Ulrych J, Zachariah SK, Catena F. 2020 update of the WSES guidelines for the management of acute colonic diverticulitis in the emergency setting. World J Emerg Surg. 2020 May 7;15(1):32. doi: 10.1186/s13017-020-00313-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: infection; intra-abdominal; complicated; greek
• Additional Relevant MeSH Terms: Infections; Intraabdominal Infections
• Other Study ID Numbers: HERCO-II 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No